Lecture 1 Flashcards by Alexander Lee

How to avoid a control group?

Less intervention vs more intervention

one approved intervention vs experimental intervention

How well did you know this?

Not at all

Perfectly

What are the 3 levels of IRB review (institutional review process)

Full, Expedited, Exempt

note: at TWU all IRB appliations must be completed using CAYUSE

How well did you know this?

Not at all

Perfectly

“Full” level IRB

More than minimal risks to patients

Sensitive topics

Vunerable populations

How well did you know this?

Not at all

Perfectly

Expedited IRB level

No more risk than daily life
- blood draws, physical exam, routine testing

non-interventional studies (observational)

Surveys of nonsensitive nature

Genomic studies

Electrophysiological studies

Non-invasive imaging

Collection of existing data for meta-analysis

How well did you know this?

Not at all

Perfectly

“Exempt” IRB level

Little to no risk

No sensitive topics

No minors

Example: anonymous survey

How well did you know this?

Not at all

Perfectly

For a FULL IRB, who reviews it?

for Expedited, who reviews it?

For exempt, who reviews it?

The entire board

subset of the board

The chair of the board gives exempt status

How well did you know this?

Not at all

Perfectly

Participants must be fully informed of risk, and must be anonymous

Informed Consent forms must be atleast _____ reading level

researchers must answer questions from participants throughout

there can be no penalty for withdrawing

participants must sign ________ page and they get a copy

6th grade

every

How well did you know this?

Not at all

Perfectly

T or F, you can be an author on the manuscript even if your name isnt in the IRB

True

How well did you know this?

Not at all

Perfectly

After data collections what must researchers do

Close IRB and submit all signed consent forms

they can still analyze the data after IRB is closed

How well did you know this?

Not at all

Perfectly

What is included in evidence based practice?

integration of best evidence, clinical expertise, and patient values

How well did you know this?

Not at all

Perfectly

What does PICO stand for

Patient

Intervention

Comparison

Outcomes

How well did you know this?

Not at all

Perfectly

What does FINER stand for

Feasible
Interesting
Novel
Ethical
Relevant

How well did you know this?

Not at all

Perfectly

What are strengths of primary evidence (RCT, Cohort Studies, Case Control Studies)

Current, Availible online in full text

How well did you know this?

Not at all

Perfectly

What are weaknesses of primary evidence (RCT, Cohort Studies, Case Control Studies)

For all except PEDro you still need to read and extract info

only finds articles listed in specific search engine

How well did you know this?

Not at all

Perfectly

What are strengths of secondary evidence (meta analysis, systemic review, text book)

Summarizes info for you

you dont have to read all the articles individually

How well did you know this?

Not at all

Perfectly

What are weaknesses of secondary evidence (meta analysis, systemic review, text book)

Some more comprehensive than others

Always dated

How well did you know this?

Not at all

Perfectly

systematic review vs meta analysis

Systematic review- asks question and preforms comprehensive literature review to make clinical practice recommendations

meta analysis - systematic review+ that also combines all the data and presents overall results of data

How well did you know this?

Not at all

Perfectly

T or F: Absence of evidence is the same as negative evidence

How well did you know this?

Not at all

Perfectly

LEVELs of evidence vs Grades

Levels- for individual studies

1a 1b 1c…..

Grades- summarizes multiple studies

A B C D E F

How well did you know this?

Not at all

Perfectly

1a evidence

systemic review of RCT

How well did you know this?

Not at all

Perfectly

1B evidence

RCT with narrow CI

How well did you know this?

Not at all

Perfectly

1c evidence

All or none

2a evidence

systemic review of cohort studies

2b evidence

cohort study or low quality RCT

2C evidence

Outcomes research

3a evidence

systemic review of case-control studies

3b evidence

individual case control studies

4 evidence

case report, small case series

5 evidence

Expert opinion, bench (animal) research

What is all or none evidence?

Some patients died and now none do OR All patients died and now some survive

What does a SMD (standard mean difference) measure

effect size

how to calculate SMD?

(Mean 1 - Mean 2) / (( SD 1 + SD 2)/2) Difference of means divided by average standard deviation

What do the larger dots mean?

Larger dot = larger effect size

What does a confidence interval measure?

Measures the **precision** of an **estimated value**

Grade A evidence

A lot of level 1 and Level 2 studies support the recomendation (must have atleast one level 1 study) STRONG EVIDENCE

# ``` Grade B evidence

A single high quality RCT supports this, or multiple level two studies MODERATE EVIDENCE

Grade C evidence

A single level two study supports this or multiple 3 and 4 studies, including statement of consensus by experts WEAK EVIDENCE

Grade D evidence

High quality studies disagree conflicting evidence

Grade E evidence

A lot of evidence from animal/cadaver studies or from conceptual models theoretical/foundational evidence

Grade F evidence

Expert opinion

What is PEDro?

Ranks RCT by quality 0-10 6+ is considered high quality

What is quadas?

A tool to measure quality of study 0-14 7+ is a high quality study

Who is the first author in a study?

Writes first draft/ designer of study

Who is the last author in a study?

Experienced investigator who partners with first author for analysis

Who is the second author of a study?

Major contributor

The person who writes the bulk of the manuscript tends to be the ________ author

first

What is an abstract?

150 words or less addresses primary purpose, none of secondary findings (summary)

Parts of abstract:

Background Study Purpose Overview of methods Main findings Primary conclusion

T or F At the end of the day you can never prove an alternative hypothesis, but you can reject your null hypothesis or fail to reject the null hypothesis

True

Where can you look in a study to find info on the participant numbers throughout a study?

Consort diagram, usually placed in "methods", can also be placed in "procedures" section

Where can you find the inclusion/exclusion criteria for a study and the power analysis ?

Methods

Where can you find the instrumentation of the study and the data analysis ?

In the methods section

T or F: Authors interpretation of results goes into the "Results" section

Where can you find "clinical implications" of a study?

In the discussion section