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Research or Audit?. Nina Dunham R&D Manager. Introduction. What is Research? What is Audit? Why Research & Audit get confused? How the Trust processes research & audit. Research.
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Research or Audit? Nina Dunham R&D Manager
Introduction • What is Research? • What is Audit? • Why Research & Audit get confused? • How the Trust processes research & audit
Research • A systematic investigation undertaken to discover facts or relationships and reach conclusions using scientifically sound methods. (Hockey, 1996)
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
Research • Significance – Statistical difference (hypothesis driven) • Outcome – Improve knowledge • Results, publications – Generalisable, publishable in peer reviewed journals • Findings influence clinical practice as a whole
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
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
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)
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
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
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
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
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.
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
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”
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
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
Further Information • Research Dept – R&D Admin Porta Cabin, CHH • Research Staff • Intranet Pages • Audit Dept – Hull Royal Infirmary • Audit Staff • Intranet Pages • University Web Site
Conclusion • What is Research? • What is Audit? • Why Research & Audit get confused? • How the Trust processes research & audit • Where to find further information