Question 1 · Law, Ethics & Human Factors · Easy
A paramedic on an ambulance trust's research and audit group is asked to classify two proposals. Project 1 will check, for every eligible major trauma patient over six months, whether tranexamic acid was given within three hours of injury as the trust guideline requires, and feed the results back to stations. Project 2 will randomise eligible patients to one of two pre-hospital analgesic regimens to find out which gives better pain control. Using the HQIP definitions, which classification is correct?
- ABoth Project 1 and Project 2 are clinical audit
- BBoth Project 1 and Project 2 are research studies
- CProject 1 is research; Project 2 is clinical audit
- DProject 1 is research; Project 2 is service evaluation
- EProject 1 is clinical audit; Project 2 is research
Show answer
Answer: E
Project 1 is clinical audit; Project 2 is research
HQIP defines clinical audit as a quality improvement cycle that measures the effectiveness of healthcare against agreed and proven standards and takes action to bring practice in line with them. Clinical audit tells us whether we are doing what we should be doing and how well; research is about obtaining new knowledge and finding out which treatments are the most effective. Project 1 has an explicit standard (tranexamic acid within three hours, as the trust guideline requires), measures compliance and feeds back to change practice — the audit cycle. Project 2 randomises patients between two regimens to find out which works better — research by definition, however routine the setting. Neither is service evaluation. Using routinely collected data, or intending to present the results, does not change the classification; the purpose of the project does. The distinction has consequences: HQIP notes that, unlike research, clinical audit does not need research ethics committee approval, and the ABC points out that consent for clinical trials is governed by legislation, with provision in emergencies for assent and later full consent.
Where this comes from
- HQIP — What is clinical audit and other frequently asked questionsHealthcare Quality Improvement Partnership·What is clinical audit? (HQIP definition)“a quality improvement cycle that involves measurement of the effectiveness of”Open PDF at page 2
- HQIP — What is clinical audit and other frequently asked questionsHealthcare Quality Improvement Partnership·Difference between clinical audit and research“Research is about obtaining new knowledge and finding out what treatments are the most”Open PDF at page 3
- HQIP — What is clinical audit and other frequently asked questionsHealthcare Quality Improvement Partnership·Difference between clinical audit and research“Clinical audit tells us whether we are doing what we should be doing”Open PDF at page 3
- HQIP — What is clinical audit and other frequently asked questionsHealthcare Quality Improvement Partnership·Difference between clinical audit and research: ethics approval“clinical audit does not need approval from a research ethics”Open PDF at page 3
- ABC of Prehospital Emergency Medicinep. 207Ch. 38 Research and Development in Prehospital Emergency Medicine · Consent for clinical trials“Consent for clinical trials is governed by legislation”