General research questions Flashcards
What makes a good research question?
FINER
Feasible (answerable with a robust method) Interesting Novel Ethical Relevant
What do you need to consider about the methodology of a paper?
Patients - disease or condition - stage, severity - demographic characteristics (age, gender, etc.) Intervention - type of intervention or exposure - dose, duration, timing, route, etc. Comparison - risk or treatment - placebo or other active treatment Outcome - frequency, risk, benefit, harm - dichotomous or continuous - type: mortality, morbidity, quality of life, etc.
What is the role of an educational supervisor?
- registered and licensed medical practitioner
- trained to be responsible for the overall supervision and management of a specified foundation doctor’s educational progress
What is the role of a clinical supervisor?
- registered and licensed medical practitioner
- trained to be responsible for overseeing a specified foundation doctor’s clinical work and providing
constructive feedback during a training placement.
What is the role of an academic supervisor
- medical academic (may or may not be a clinician)
- oversee academic work
- provide constructive feedback through project
- advise on academic careers
What are the phases of clinical trials
Phase I: Researchers test a new drug or treatment in a small group of healthy people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug’s effect in various populations and any side effects associated with long-term use.
What is the MHRA?
Recognised globally as an authority in its field, the agency plays a leading role in protecting and improving public health and supports innovation through scientific research and development.
Developed the yellow card scheme
Aims:
- Operate post-marketing surveillance for reporting, investigating and monitoring of adverse drug reactions to medicines and incidents with medical devices.
- Assessment and authorisation of medicinal products for sale and supply in UK.
- Oversee the Notified Bodies that ensure medical device manufacturers comply with regulatory requirements before putting devices on the market.
- Operate a quality surveillance system to sample and test medicines to address quality defects and to monitor the safety and quality of unlicensed products.
- Investigate internet sales and potential counterfeiting of medicines, and prosecute where necessary.
- Regulate clinical trials of medicines and medical devices.
- Monitor and ensure compliance with statutory obligations relating to medicines and medical devices.
- Promote safe use of medicines and devices.
- Manage the Clinical Practice Research Datalink and the British Pharmacopoeia.
What are the five steps of evidence based medicine?
- Define question
- Find best evidence
- Appraise evidence for validity
- Integrate findings with clinical expertise and patient views
- Audit clinical practice
How do you undertake an audit?
- Select a topic
- Identify an appropriate standard
- Collect data to assess performance against standard
- Implement changes to improve care
- Collect data to reassess
What is PRISMA?
PRISMA is an evidence-based minimum set of items for reporting in systematic reviews and meta-analyses.
What makes a good screening programme?
The condition:
- Important health problem
- Primary prevention implemented as far as possible
- Natural history of disease well understood
The test
- Safe and valid screening test
- Acceptable to the population
- Clear diagnostic cut off
- Agreed protocol for positive results
The intervention
- Evidence based, effective intervention
- Benefit of intervening early
The screening programme
- Effective at reducing mortality and morbidity
- Clinically, socially and ethically acceptable to health professionals and the public
- Benefits outweigh overall harms (false positives, test complications)
- Cost benefit
What are the disadvantages of an academic career?
- less time
- less money
- less time to develop clinically particularly surgical skills
What are the advantages of an academic career?
- Forefront of medical interventions
- Access to teaching opportunities and research techniques
- Meeting other clinical academics - discussions etc.
- Benefit to clinical work of understanding the literature
How do you apply for ethical approval?
Need to apply for NHS ethical approval if using NHS server information UNLESS: it has already been collected as part of treatment and is anonymised
Also may need to complete local ethics committee applications forms e.g. Cambridge Human Biology Research Ethics Committee
Information collected depends on research and discipline but addresses:
- Autonomy
- Maximising benefit
- Minimising harm
- Confidentiality
- Consent
- Equity
- Behaving with integrity
The research ethics guidebook is a useful online resource
What is IRAS
The Integrated Research Application System (IRAS):
Is a single system for applying for the permissions and approvals for health and social care / community care research in the UK
Enables you to enter the information about your project once instead of duplicating information in separate application forms
Uses filters to ensure that the data collected and collated is appropriate to the type of study, and consequently the permissions and approvals required
Helps you to meet regulatory and governance requirements
