Health care research Flashcards
Why might healthcare research be done?
Prevent illness
Detect or diagnose illness
Treat illness
Improve quality of life
Support patients/staff
Improve clinical effectiveness
Value for money
Who needs to go through the approvals process before undertaking research?
Anyone wanting to undertake research using NHS patients, staff, facilities or data
What is a clinical audit?
A quality improvement process
A way to understand whether a clinical service is meeting defined standards of best practice
A clinical audit is therefore designed to answer the question “does this service reach the standard?”.
5 steps to take when carrying out a clinical audit
- Identify a problem or issue
- Look at the set criteria & standards that already exist
- Observe practice / data collection
- Compare current performance with criteria and standards
- Implement change if required
What is a service evaluation?
A way to define or measure current practice within a service.
The results of the service evaluation help towards producing internal recommendations for improvements of that service alone
A service evaluation is designed to answer the question “what standard does this service achieve?”
Look
Results of research, or the theories gained from the research, should apply beyond the sample of the population upon which the research is based.
Aim of healthcare research
Generate new knowledge
Generalisable or transferable beyond the sample of population that the research is based on
Who regulates/sets guidelines for research in the UK?
Research governance framework
In what way does the governance of research improve the quality of research and safeguard the public?
It enhances the ethical and scientific quality - would be unethical to ask patients to take part in poorly run research
Promotes good practice
Reduces adverse incidents and ensuring lessons are learned
Forestalling poor performance and misconduct
What is a research sponsor?
Institution or organisation; ultimate responsibility for the initiation, management, financing (or arranging the financing) for that research. They arrange the contracts etc
Any research requiring the collaboration of the NHS must have an individual or organisation willing and able to take on the responsibilities of the research sponsor.
You must already have a prospective sponsor before applying for research
Who’s responsibility is it for ensuring that the design of the study meets appropriate standards and that arrangements are in place to ensure appropriate conduct and reporting?
The research sponsor
What happens if there is co-sponsorship?
Delegation of duties between the 2 sponsors in particular those relating to monitoring of the research and provision of insurance or indemnity (if something goes wrong) should also be provided.
Who’s responsibility is it to ensure that the sponsor(s) are aware of their proposal and accept their responsibilites?
Chief investigator
Where did the Northwick Park drug trial go wrong?
When one patient started to develop alarming side effects to the drug the researchers continued to administer the drug to other patients which is contrary to the clinical protocol
Although they didn’t die, some patients experienced multi-system failure and were left with long-lasting side effects from that drug
What went wrong with Dr Green’s research regarding women and carcinoma in situ of the cervix
The women themselves did not know they were taking part in a research study. They came into clinic for smears, treatment etc and didn’t know the treatment was experimental and that there were other treatment options.
They had not consented!
