lecture flashcards need to know

What is PICO

• Population

• Intervention

• Control

• Outcome

In PICO, what does population mean

Who are the patients being studied

In PICO, what does intervention mean

What treatment are the researchers investigating

In PICO, what does outcome mean

What are the researches measuring

What does primary literature mean

Where reachers collect there own data- original research data

How many different primary literature are there

3

Name the three different primary literature

• randomised controlled trail

• Cohort study

• Case control study

What does randomised controlled trail mean

• participants randomly assigned to groups

• Minimises bias and confounding

• And it is the gold standard for testing effectiveness of intervention

What does cohort study mean

• follows a group over time to observe outcomes based on exposure

• Can be prospective or retrospective

• Useful for studying risk factors or long-term effects

What does it mean by case control study

• it starts with people who have an outcome and compare them to those who don’t have an outcome

• Look backwards to identify exposure or risk factors

• Useful when studying rare diseases or outcomes

What does secondary literature mean

It’s an combination or summaries of existing studies

How many secondary literatures are there

2

Can you name the 2 different secondary literatures

• systemic review

• Meta-analysis

What does it mean by systemic review

It is a structured summary of high quality studies on a specific question

Uses pre-defined criteria and methodology

What does it mean by meta-analysis

It combines statistical data from multiple studies to give a polled estimate of effect

It increases power and precisions

What does it mean when a study is non-randomised

• allocation is not by chance

• Higher risk of selection bias

What does it mean when a study is randomised

• participants are assigned to groups by chance

• Helps to ensure groups are similar at baseline

• Reduces selection bias and confounding

• Allows valid comparisons to be made between the intervention and control groups

• Enhances internal validity

What does it mean when a study is randomised

• participants are assigned to groups by chance

• Helps to ensure groups are similar at baseline

• Reduces selection bias and confounding

• Allows valid comparisons to be made between the intervention and control groups

• Enhances internal validity

What is the difference of a randomised test and blinding

Randomisation deals with WHO goes into which group.

Blinding deals with WHO knows what treatment they got.

How many groups of blinding are there

Three

What does it mean by open-label blinding

• no blinding- everyone involved knows who receives which treatment

• Often used when blinding is not feasible

• Potential for bias from patients/researcher

What does it mean by single- blind blinding

• participants do not know which treatment they recover but the researchers do

• Helps to reduce placebo effects

What does it mean by double-blind blinding

• nether the participants nor the researchers know who receives which treatments

• It reduces performance ad detection bias

What does it mean if a study is single- centre

It is conducted at one location

What are the benefits of single centre

• easier to manage

• More consistent

What are the limitations of single- centre

• less generalisable (limited external validity)

What does it mean by multi-centre

• conducted at multiple locations

What are the benefits of multi-centre

• increases diversity and reliability of results

• Border applicability across populations

What are the limitations of a multicentre

• risk of inconsistent data collection or protocol deviation between sites

How many phases are there in a clinical trail

4

Name the 4 different phases of clinical trials

1. Pilot RCT

2. Phase 1

3. Phase 2

4. Phase 3

What does it mean by pilot RCT

It is a small preliminary study conducted before a larger definitive trial

What does pilot RCT do

It tests feasibility and study procedures

Give na example of pilot RCT for my understanding

Recruitment

Data collection methods

What is phase 1

• small group of health volunteers or patietns

What does phase 1 do

It assess

• short term safety

• tolerability

• Pharmocokinetics

And determined a safe dose range

What is phase 2

It is a larger but still small groups of patients

What does phase 2 do

• assess efficiency in treating conditions

• Optimal dosing

• SHORT-TERM safety/ Side effects

What is phase 3

It is a large often multi-centre

What does phase 3 do

• it confirmed efficacy (on the wider scale)

• Monitors LONG-TERM adverse effects and compare them to standard treatment

• it is required for regulatory approval

How many different types of article publishers are there

2

What are the names of the article publishers

1. Journal impact factor

2. Peer review

What is journal impact factor

• it is a reflection of how often articles from a journal are cited

• Higher impact journals are often seen more prestigious ad influential with articles more likely to be creditable and of high quality

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What does peer review mean

• articles published in reputable ournals usually go through a peer review process where they are evaluated by independent experts before publication

What does paper review ensure through research

That it is

• valid

• Credible

• Relevant

Who normally funds research

• Pharmaceutical companies

• Government health bodies

• Academic institutions

If reach is normally funded , what can that lead into

It may influence bias when reporting or study design

In research how many different biases are there

3

Name the 3 different biases in research

1. Design bias

2. Publication bias

3. Reporting bias

What is design bias

The study may be structured to favour the sponsors product

What is publication bias

Positive results are more likely to be published and negative or inclusive results may be withheld

What is reporting bias

It is selective reporting of outcomes tha favour the intervention, unfavourable dat a