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Published byAmbrose Smith Modified over 9 years ago
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MJ Macleod on behalf of SSCA Research Subgroup
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Terms of Reference To improve the care of patients who have suffered from a stroke in Scotland To manage the clinical governance aspects of audit, ensuring that appropriate action is taken To plan the medium and long-term strategy of audit, taking into account the national strategy for audit as determined by NHSQIS and delivered by ISD To direct the clinical content of the annual report and approve the release of any other routine data analyses produced by the group To maximise the use of the data by identifying research potential and establishing associated research projects To establish sub-groups with a remit to address specific issues (e.g. sprint audits, report writing, clinical governance) To provide clinical advice and support to the project management team
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The audit helps drive service improvement by feeding back to MCNs and Health Boards areas of good and poor performance.
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What else could audit data be used to facilitate? Adherence to national clinical guidelines Equity of healthcare delivery (age, sex, health care providers, geographical location, etc)
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What else could audit data be used to facilitate? Adherence to national clinical guidelines Equity of healthcare delivery (age, sex, health care providers, geographical location, etc) ‘Service epidemiology’ (are interventions working in routine care, satisfaction with stroke services)?
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What else could audit data be used to facilitate? Adherence to national clinical guidelines Equity of healthcare delivery (age, sex, health care providers, geographical location, etc) ‘Service epidemiology’ (are interventions working in routine care, satisfaction with stroke services) Simple epidemiology (socioeconomic factors, quality of life, depression, pain, fatigue)?
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SSCA (40,000+ patients) SMR01 (Similar/different to SSCA data?) Mortality data Diabetes Renal registry SICSAG (Intensive care) PCCIU PACS
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Lots of unanswered questions regarding stroke care in Scotland ◦ Geographical issues and outcome ◦ Secondary prevention and outcome ◦ Impact of thrombolysis on stroke outcomes etc etc
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No effective therapies What about interaction with antiplatelet and antithrombotic agents? Outcomes?
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Some data/evidence for components of the ‘black box’ Currently SSCA data not linked to SMR01/mortality data
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Using stroke registers for research: Example from RIKS stroke in Sweden
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Riks-Stroke national database Registration of patients at local hospital via the Internet Simple statstical analysis of local hospital data online More extensive reports of data from Riks-Stroke once a year
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Number of patients included in Riks- Stroke Data from2003/BS 1994 1995 1996 1997 19981999200020012002 0 5000 10000 15000 20000 25000 0 5000 10000 15000 20000 25000 193 700 events 20032004
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Stroke units vs. general wards – functional outcome at 3 months 0 20 40 60 80 Age standardised data and only patients fully conscious at admission are included Living independently at home Independent mobility Independent in primary ADL General wards Stroke units p<0,0001 %
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1995199619971998199920002001 0 5 10 15 3-months case fatality (only patients independent and fully conscious at onset) All ages SU GW %
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Copyright ©2010 American Heart Association Persistent use of Secondary preventive drugs declines rapidly in the first 2 years after stroke Glader, E.-L. et al. Stroke 2010;41:397-401 Proportion of persistent users among patients discharged with drugs and still alive at the end of each time interval (RIKS register, Sweden)
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Audit vs research Consent Patient confidentiality
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All patients are given the opportunity to withdraw from the audit Posters and leaflets are available in all areas dealing with stroke patients “We want to improve the care for people with stroke symptoms by: Finding out about stroke; Finding out what causes it; Finding out what the best treament is. Your data could help us.”
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The National Research Ethics Service (NRES) has a dual mission: to protect the rights, safety, dignity and well- being of research participants; and to facilitate and promote ethical research that is of potential benefit to participants, science and society.
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7. There is no formal requirement for research databases to apply for ethical review under NHS research governance systems, and ethical and other approvals would only be required by legislation if processing identifiable data without consent. Applications for ethical review will therefore normally be made on a voluntary basis. 8. However, ethical approval for a database may have benefits by facilitating programmes of research using data on human subjects without a need for individual project-based ethical approval. The database application form has an option for the applicant to seek generic ethical approval, subject to conditions agreed with the REC (see paragraphs 16-20 below).
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Linkage by CHI within ISD Anonymisation before release to investigators SSCA Research subgroup (MJM, PL, MD, MB) Review of proposals for use of SSCA data/linkage ◦ Proforma: clear statement and guidelines for data use ◦ PAC at ISD for linkage studies
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Ethical approval being sought Discussion with ISD regarding linkage and release of data Proforma for use of data Grant application for data manager/facilitator Maintaining patient confidentiality paramount
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