1. Nina Dunham R&D Manager
Research or Audit?
Nina Dunham
R&D Manager

2. Introduction What is Research? What is Audit?
Why Research & Audit get confused?
How the Trust processes research & audit

3. Research
A systematic investigation undertaken to discover facts or relationships and reach conclusions using scientifically sound methods.
(Hockey, 1996)

4. Research
Purpose – To provide new knowledge in order to set or change standards
Methods – Randomised Trials etc…
Data Analysis – Extensive statistical analysis
Ethical & Trust Approval – Always required
Sample size – statistically powered calculation

5. Research Significance – Statistical difference (hypothesis driven)
Outcome – Improve knowledge
Results, publications – Generalisable, publishable in peer reviewed journals
Findings influence clinical practice as a whole

6. Example of Research
Purpose – comparing recovery rates in surgical procedure A compared to surgical procedure B in patients with diabetes over the age of 65
Method – Randomised Clinical Trial (RCT)
Data Analysis – Statistical analysis
Sample size – n = statistically powered calculation
Significance – statistical p value

7. Example of Research
Outcome – Emperical Data which can be compared to existing knowledge and utilised in the decision making to use surgical procedure A as opposed to B
Results – Generalisable, results can influence clinical practice as a whole, accepted and published in peer reviewed medical journals

8. Audit
A quality improvement process that seeks to improve patient care and outcomes -through systematic review of care - against explicit criteria and the implementation of change (NICE 2003)

9. Audit
Audits are cyclical – ie completion of audit cycle includes identifying areas of non-conformity with evidence based standards implementing practice changes to address these and then re-auditing standards of care

10. Audit Purpose – Tests conformity with evidence based standards
Methods – Never involves allocation to different treatment groups
Data analysis – Simple statistical analysis eg descriptive and unadjusted comparisons such as t-tests
Ethic approval – not necessarily required

11. Audit
Sample size – sufficiently large case number to influence practice based on audit findings
Significance – Clinically meaningful performance indicators set against standards
Outcome – Improved clinical practice
Results – Audit methods and findings are usually locally implemented

12. Example of Audit
Purpose – Surgical procedure A is recognised as a gold standard for patients over the age of 65 with diabetes
Method – Case note review
Data Analysis – Percentage of cases reviewed which meet the criteria
Sample size – not statistically powered

13. Example of Audit
Significant – acceptable adherence threshold may be set 100%, 90% or 80% dependent on practice being audited
Outcome – improved clinical practice
Results – Relevant to designated setting. Audit methods and findings may be of wider interested to be published.

14. Similarities between Research & Audit
Research & audit involve answering a specific question relating to quality of care
Both can be carried out either prospectively or retrospectively
Both involve careful sampling, questionnaire design and analysis of findings
Both activities should be professionally led

15. How the Trust processes Research & Audit
The NHS clinical effectiveness initiative explicitly links research and clinical audit,
“without research we won’t know what clinically effective practice is”
“without audit we won’t know whether it is being practised”

16. How the Trust process Research & Audit
In order to conform with the Research Governance Framework all research projects must have Ethical & Trust approval
All Audit projects have to be processed through the Audit department using the CG1 form

17. How the Trust process Research & Audit
What happens when there is a difference of opinion?
Discussion between Ethics, Research & Audit dept
Research Executive Group
Medical Director

18. Further Information Research Dept – R&D Admin Porta Cabin, CHH
Research Staff
Intranet Pages
Audit Dept – Hull Royal Infirmary
Audit Staff
University Web Site

19. Conclusion What is Research? What is Audit?
Why Research & Audit get confused?
How the Trust processes research & audit
Where to find further information