Exam Two - RCT Part Two Flashcards
RCTs are level:
1b and 2b
what does PEDro score?
internal validity
how many questions does PEDro have? What is it scored out of? What does a higher score mean?
11
scored out of 10
higher score means greater internal validity
What is considered a good PEDro score for this class?
greater than or equal to 6
1
eligibility criteria was specified
* this question doesn’t get actual points
2
subjective were randomly allocated to groups
“random number generator”
3
allocation was concealed
“opaque, nontranslucent, numbered envelopes”
4
the groups were similar at baseline regarding the most important prognostic indicators
(was random assignment effective??)
5
there was blinding of all subjects
(must be blind at all points)
6
there was blinding of all therapists who administered therapy
(must be blind at all points)
*very difficult to do
7
there was blinding of all assessors who measured at least one key outcome
(must be blind at all points)
8
measures of al least one key outcome were obtained from more than 85% of the subjects initially allocated to groups
- addresses potential loss of stat power and survivorship bias
- if several follow up time points, only required at one of the post tests
10
results of between-group stats comparisons are reported for at least one key outcome
(could be between two different groups or a pre/post test)
9
bonus points for NO drop outs
If no dropouts, you still get point if you used ITT analysis
11
study provides both point measures and measures of variability for a least one key outcome
- average & SD most common. probs provided via graph
survivorship bias
you stay in the study because you’re doing well
is a p value required for a between group comparison?
no
what could you use instead of a P value for a between group comparison?
confidence interval AND
- between group mean diff
- diff in proportions
- number needed to treat
- relative risk
In PEDro, what is the mean score? how many article are a 6 or above?
5.2
40%
what are the most common missing elements in PEDro?
1 - blind therapist
2 - blind subjects
3 - ITT analysis
blind assessors and concealed allocation tied for 4th
does PEDro sub for your critical appraisal?
no
does PEDro recognize inappropriate stats?
no
does PEDro establish clinical relevance/magnitude of effect
no
does PEDro evaluate for external validity
no
does PEDro provide a comprehensive assessment of internal validity?
no (it won’t establish if the research design is even appropriate for the research question)
does PEDro assess if outcomes were appropriate, reliable, and valid for the purpose of the study?
no
does PEDro assess if groups were treated the same way (except for experimental intervention)
no
What questions should you ask yourself when trying to integrate RCT results into your clinical practice?
- is it a high quality RCT? (appropriate stats? effect size?)
- is there a preponderance of evidence?
- does the study generalize well to my practice/pts?
