MR910 - Evaluation of predictors of cardiovascular morbidity and mortality in patients with arthritis

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 The Dudley Group NHS Foundation Trust 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 information provides background information on the purpose of the original study:

Cardiovascular disease (CVD) is the commonest cause of death in patients with rheumatoid arthritis (RA) accounting for up to 55% of all deaths. Standardised mortality ratios range from 1.13 to 5.25 for cardiovascular death in RA. The excess CVD is thought to be due to premature development of ischaemic heart disease, secondary to accelerated atherosclerosis. This is supported by studies showing an excess of deaths due to coronary heart disease (CHD).

Recent research from this group has identified twice the prevalence of CHD in RA patients compared to matched controls, with CHD occurring on average 10 years earlier in the RA patients and showed also that RA patients who suffered an acute coronary syndrome have a worse outcome than non RA patients. The underlying mechanisms for the high prevalence of CHD in RA are not currently fully understood and the evidence that cardiovascular disease is the main contributor is still indirect.

The use of inception cohorts, such as the Framingham Study, have helped develop models that predict the likelihood of developing CHD in the future in the general population, based on particular risk factors (e.g. age, sex, smoking, blood pressure etc.). Epidemiological research in RA suggests that such models underestimate CHD risk in patients with rheumatoid arthritis, probably because other factors may be equally or more important. Such factors may include demographic details; social and quality of life factors (e.g. socioeconomic status, disability, quality of life measurements); the extent of inflammation measured clinically; drugs used for the treatment of RA; pre-existing cardiovascular disease; as well as novel risk factors (such as hyperhomocysteinaemia, blood clotting mechanisms, insulin resistance) or newly described genetic factors.

There is currently no prospective study trying to identify RA-specific CHD risk factors, and this is the main objective of the current proposal.

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 study data, including data provided by NHS Digital under previous agreements, are currently held by The Dudley Group NHS Foundation Trust.

The following provides background on the processing activities undertaken prior to this Agreement:

Identifiable data was shared with ONS to carry out the linkage between the study data and civil registration data. Participants records were ‘flagged’ with the Office for National Statistics (ONS). ONS notified the study team at The Dudley Group NHS Foundation Trust of participants’ deaths (date and cause) and cancer events when they occurred. The ‘flagging for long-term follow up’ service transferred from ONS to the HSCIC in 2008. Data was last supplied in March 2018.

Consecutive patients with an established diagnosis of rheumatoid arthritis (meeting retrospective application of the 1987 ACR classification criteria) were recruited from routine rheumatology out-patient clinics at the Dudley Group of Hospitals. Consenting patients were asked to complete 2 questionnaires: the Euorquol-5 and the Health Assessment Questionnaire (HAQ).

The investigator recorded details: Name, Address (with postcode), Sex, Date of Birth, Unit number, NHS number, Ethnic group. Details were also recorded about their arthritis, other past medical history and relevant other details such as smoking history and Blood pressure. The patients had an ECG which would be reviewed and coded using the Minnesota code. The ECG is stored with the rest of the patient's documents and a copy is kept in the patient case notes. Patients are asked to attend a research clinic in the next two weeks to have fasting blood samples carried out.

Cardiovascular death is a primary outcome measure in this study. Due to the length of the study and population movement, each patient recruited into the study is flagged for long-term follow up with NHS Digital. On the event of the death of a participating patient, NHS Digital has notified the study of the cause of death, or sent a copy of the death certificate. The information provided identifies patients that have died from cardiovascular disease and thus enables an evaluation of the predictors of cardiovascular disease in patients with RA.

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.

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

The data has already provided numerous academic published papers since 2003 and has been the basis of three PhD and one MD theses. Findings have also contributed towards the re-writing of national and international guidelines for the management of patients living with rheumatoid arthritis. The data has also been used to develop patient education material about cardiovascular risk in RA.