EBM Flashcards
what is the concern about the overlap between QI studies and clinical research trials?
QI studies randomizing patients to risky clinical trials
what is the challenge of public health research?
the potential need for informed consent for all potentially affected individuals
seek to analyze individual poor outcomes to indentify their root cause and look at processes of care to identify which practices have the best outcomes
QI studies
the biggest difference between clinical research and public health
whether the intervention will be directed at an individual level or a population level
studies interventions aimed at individuals
clinical research studies
explores how to provide interventions to broader populations
public health
what is the most secure way to assure participant privacy?
anonymous data collection
review research protocols to ensure they meet scientific and regulatory standards
IRB
concerns have recently been raised about the privacy protection of DNA because
DNA from existing samples can be traced back to the original donors or relatives
factors that may influence how patients and their families feel about controversy
- history of research abuse
- poor access to care
- health care disparities
what can minimize the risk of differential recall?
standardized questionnaires
generates a sample that is not representative of the larger population
selection bias
test performance is assessed using a […] study
cross sectional
use groups of people as the unit of analysis and are well-suited to looking at policy related changes
ecologic studies
includes a structured plan for considering scientific literature around a focused study question
systematic review
less expensive than cohort studies and can be conducted faster
case-control studies
researchers start with outcome of interest and look backwards in time for the exposure of interest
case-control
researchers first ask about exposure and follow people forward in time to look for the development
cohort study
[…] studies are well suited to rare exposure
cohort
[…] studies are well-suited to rare outcomes
case-control
two items being addressed in a single question
double barreled
suggests to the respondent that the researcher expects or desires a certain answer
leading question
what helps control for unobservable characteristics?
way to address potential bias
randomization
actual application of calculation from a number of studies
meta-analysis
what part of PICO is the DV?
outcome
what part of PICO is the IV?
intervention
what part of PICO is the population/study sample?
patient & problem
yes/no
what
questions are examples of..
quantitative
Why?
How?
questions are examples of…
qualitative
anything about perceptions, access, value is a [….] question
qualitative
- closed-ended surveys/questionnaires
- observed and recorded
- measured and recorded
- existing datasets or subsets there of
qualitative or quantitative
quantitative
- open ended survey
- interviews
- focus groups
- ethnography
qualitative or quantitative
qualitative
most popular form of scaling
likert scales
medians and frequencies of likert data can be analyzed via
chi square test
means of likert data can be analyzed via
t test
unlike ranking, allows participants to give different items the same answer
ratings
do you agree?
how much do you agree or disagree?
examples of…
loaded language
How satisfied are you with the quality of your teamwork and your progress on your protocol so far?
example of…
double barreled question
assessing two things
do you spend any time?
how much time do you spend?
examples of …
categories that influence bias
phases of drug development
5
0) exploring if/how new drug may work
1) is the treatment safe?
2) does the treatment work?
3) is it better than what is already available?
4) post marketing surveillance
When does the project shift from QI to research?
3
- systematic data collection
- wanting to contribute to generalizable knowledge
- intent to publish
greatest association with preterm labor
poverty
[…] were causing oxidative damage to lung/eyes in premature infants
high oxygen concentration
range of oxygen saturation that minimizes the risk of retinopathy?
85-95%
group that looks for emerging differences between arms and may recommend stopping trials early if there is significant risk or benefits to one arm vs. the other
DSMB
DSMB may stop a trial early if
one arm experiences clear benefits or risks over the other
the BOOST II investigators saw increased […] in the lower oxygen group and […]
increased death rates
stopped the trial
medical malpractice requires 4 things
- duty of care
- breach of that duty
- harm caused to the patient
- causality: the harm is due to the breach
why might participants at UAB be sensitive to abuse in research?
3
- higher rates of prematurity with racial disparity
- high rate of uninsurance
- proximity to tuskegee
registry data after the UAB oxygenation study actually showed higher mortality rates in
those not enrolled in the reasearch study
both arms of the trial actually had improved mortality
perhaps due to guideline based protocols
why did the infants enrolled in the study have improved mortality over those not enrolled?
research inclusion benefit
