Nina Dunham R&D Manager 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 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