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HaDPop > 7.1 Randomised controlled trials > Flashcards

7.1 Randomised controlled trials Flashcards

1
Q

RCT stands for ?

A

randomised controlled trials

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2
Q

Clinical trial :

any ..1… that prospectively ..2… or groups of humans to one or more ..3..to evaluate the effect on health outcomes

any form of …4… experiment which involves ..5.. and is designed to elucidate the most ..6… of future patients with a given medical condition

A
  1. research study
  2. assigns human participants
  3. health-related intervention
  4. planned
  5. patients
  6. appropriate method of treatment
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3
Q

What are the steps to an RCT ?

A
  1. formulate a hypothesis
  2. identify population of interest
  3. eligibility criteria (define inclusion + exclusion criteria)
  4. allocation (randomly allocate to intervention + control group)
  5. controlled conditions
  6. follow-up two groups equally and minimise loss to follow up
  7. measure outcomes
  8. compare outcomes (compare findings between intervention group and placebo)
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4
Q

why is randomisation so important ?

A
  • to eliminate bias (known and unknown )
  • to balance 2 groups for known / unknown confounding factors
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5
Q

non-random assignment risks what type of bias ?

A

allocation bias

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6
Q

what is allocation concealment ?

A

when the person randomising does NOT known what the next treatment allocation will be

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7
Q

What does allocation concealment :

  1. avoid ?
  2. ensure ?
A
  1. allocation bias
  2. adequate random allocation, sequence generation & adequate allocation concealment
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8
Q

placebo effect =

experimental results caused by ..1.. alone

any effect on ..2… caused by the administration of an ….3… or condition which the recipient assumes is an ..4..

A
  1. expectations
  2. behavoir
  3. inert substance
  4. active agent
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9
Q

What is a placebo ?

A

inert substance made to appear identical in every way to the active formualtion with which it is to be compared e.g. appearance, taste, texture, dosage, regime, warnings etc.

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10
Q

what is the placebo important to?

A

cancel out any ‘placebo effect’ that may exist in the active treatment

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11
Q
  1. Blinding (masking) is a procedure in which a person involved in the study is prevented from … ?
  2. who could be blinded ?
A
  1. knowing which treatment a participant is receiving
  2. participants, clinicians, research team involved in data collection / analysis
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12
Q

Blinding/masking is important because…

A

it minimises measurement bias

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13
Q

what is the placebo group ?

A

control group exposed to inert treatment

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14
Q

losses to follow-up leads to what type of bias ?

A

follow-up (attrition) bias

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15
Q

why is there loss to follow-up in trials ?

A
  • clinical condition may necessitate their removal (appropriate)
  • they may choose to withdraw (unfortunate)
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16
Q

Intention-to-treat (ITT) analysis

  1. includes ….
  2. retains benefit of …
  3. protect against bias from …
A
  1. all data collected from participants, enven those that dropped out
  2. random assignment to groups
  3. dropout participants
17
Q

benefit of ITT (Intention-to-treat) analysis ?

A
  • preserves randomisation (minimises bias/confounding factor)
  • better reflects use in clinical practice
18
Q

Advantages of RCT

A
  • they are the ‘gold standard’ epidemiological studies
  • less risk of bias and confounding
  • provide strong evidence of causal relationships
  • can be used to study multiple outcomes
  • measure the incidence rate of an outcome
19
Q

disadvantages of RCTs ?

A
  • can be expensive
  • long follow-up period
  • ethical issues
20
Q

3 ethical codes of conduct for biomedical research ?

A
  • the hippocratic oath
  • the nuremburg code (1947)
  • the declaration of helsinki (1967)
21
Q

Nuremburg code (1947) is what ?

A

mandated volutary consent for experimental studies of humans

22
Q

describe some factors that should be considered for an RCT to be considered ethical ?

A
  1. clinical equipoise = assumption there are no other better interventions present
  2. scientifically robust = trial must address relevant/ important issue with valid question that can be answered by the chose trial design
  3. ethical recruitment = inclusion / exclusion criteria, eligibility criteria
  4. valid informed consent
23
Q

what is meant by valid informed consent of clinical trial participants ?

A
  • appropriate information provided by knowledgeable informant
  • patient must demonstrate that they understand what is involved in the trial
  • there must be no coercion or manipulation . consent must be given voluntarily

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