Ch 8 & 9 intervention studies, prevention strategies Flashcards
The only way to determine causality is through what type of study?
Intervention study.
Analytical studies only show causal “association”.
what is manipulated in an intervention study? what is the purpose of changing that variable?
investigators manipulate the exposure to see what effect it has on the outcome.
what is the ideal intervention study design and why?
randomized control trial because it can reduce bias and confounding
• recognize when non-randomized intervention studies may be appropriate
What types of controls will be used instead?
- intervention is very complex
- evidence required on a large scale
- ethical concerns with RCTs
- historical control
- geographical control
- opportunistic control
what does an intervention study measure?
the association between an outcome and exposure to a specific intervention
what form can this intervention take on?
- prevention of exposure to those at risk (insecticide infused nets to prevent malaria)
- tx to prevent death and severity in those affected (rx to prevent worsening of dz)
what form can this intervention take on?
- prevention of exposure to those at risk (insecticide infused nets to prevent malaria)
- tx to prevent death and severity in those affected (rx to prevent worsening of dz)
- remove or reduce poss risk factor (edu on risks of recreational drugs)
- increase poss protective factor (edu on vaccination)
Intervention studies are classified into what phases?
1– small trials with (2–100) healthy volunteers to assess safety and tolerability
2– efficacy and safety in larger groups of 100–300 people
3– provide definitive evidence of efficacy in those at risk, usually with RCT
4– routine use of an intervention to collect data on long-term efficacy and safety
why is an intervention study ideal for inferring causality?
- exposure identified before outcome, so can establish temporarlity.
- if the intervention reduces exposure, and thus the outcome is reduced, this establishes reversibility
- subjects can be randomized, and if large enough sample, can help to equally distribute known and unknown confounders (no selection bias)
- the intervention can be concealed, reducing information bias
what are some limitation to intervention studies?
- not good for rare outcomes
- selection bias, types of subjects that volunteer for study may not be generalizable to general public (external validity)
- expensive
- bias from types of pts loss to follow up (internal validity)
how do efficacy studies differ from effectiveness studies?
Efficacy studies– effect of intervention in experimental conditions, where max effort used to deliver intervention.
Effectiveness– real world conditions, where other obstacles may prevent the subjects from receiving the intervention.
what are some ethical issues with intervention studies?
- can’t withhold an intervention if it’s already available to the public, even though its benefits are not know (ex: screening OB US)
- can’t withhold an intervention that’s already been shown in a previous study to be beneficial (HRT reducing CAD, subsequent studies didn’t support this)
what 2 criteria make up a RCT
- existence of a control arm
2. random allocation to intervention or control group
what are the options that a Control group can receive?
- nothing
- placebo
- existing intervention
what are the 5 methods of allocation in increasing complexity order?
- simple randomization
- systematic randomization
- blocked randomization
- stratified randomization
- matched pair randomization
what are the 5 methods of allocation in increasing complexity order?
- simple randomization
- systematic randomization
- blocked randomization
- stratified randomization
- matched pair randomization
define– - simple randomization
- simple randomization: shuffle labelled cards or computer generated random number list
- systematic randomization
- blocked randomization
- stratified randomization
- matched pair randomization
define– - systematic randomization
- simple randomization
- systematic randomization
- blocked randomization
- stratified randomization
- matched pair randomization
define– - blocked randomization
- simple randomization
- systematic randomization
- blocked randomization– ensures equal number in each arm, each block is a multiple of the gp number.
ex– ABBA, BBAA, AABB - stratified randomization
- matched pair randomization
define– - simple randomization
- simple randomization: like flipping a coin, but may not result in equal # of subjects in each arm
- systematic randomization
- blocked randomization
- stratified randomization
- matched pair randomization
define– - systematic randomization
- simple randomization
- systematic randomization: subjects alternately placed in different arms, however pts on Monday may be inherently different than those on Tuesday
- blocked randomization
- stratified randomization
- matched pair randomization
define– - blocked randomization
- simple randomization
- systematic randomization
- blocked randomization: ensures equal #s in each arm, each block is a multiple of the grp #, like ABAB, BBAA, AABB, etc.
- stratified randomization
- matched pair randomization
define— stratified randomization
- simple randomization
- systematic randomization
- blocked randomization
- stratified randomization: divided into subgps by key risk factors, then equal #s into each arm using simple or block randomization (ex: stratifying infants into their villages, so effectiveness of vaccine is compared among infants of same village)
- matched pair randomization
define— matched pair randomization
- simple randomization
- systematic randomization
- blocked randomization
- stratified randomization
- matched pair randomization: a form of stratified randomization where individuals and communities are paired with another of similar baseline risk
how is the method “minimization” to allocate subjects to study arms different than the other forms?
- it is not randomized
- it’s goal is to allocate based on pre-specified criteria to get balanced arms
- good for small studies
What is the difference between allocation concealment and blinding?
allocation concealment is only concealing the allocation process, to address selection bias.
blinding is concealing from all parties to avoid other forms of bias.
what are examples of more complex RCTs?
Cluster-randomized trials
Factorial design
Crossover design
Non-inferiority and equivalence designs
when are Cluster-randomized trials used?
- when the intervention is a on a community or cluster level, like measuring air pollution
- when there’s a risk of “contamination” between control and intervention arms, like effect of educational leaflets
- however, individuals in a cluster may share characteristics that can lead to confounding
what is “factorial design”
allows for comparison of treatment A, tx B, tx A+B, and control. can save time and money.