Johns hopkins Course Module 5

Question 1

What CONSORT stands for?

Answer 1

Consolidated Standards of Reporting Trials

Question 2

standars in reporting clinical trials?

Answer 2

we have standards because, even though nobody sets out to write a bad paper, we do have papers and clinical trials that, that will have all the necessary information that people need in order to evaluate how well a trial was conducted.

Question 3

focus of CONSORT in begining?

Answer 3

parallel superiority trials

Question 4

in your words what is CONSORT?

Answer 4

25 item check list which your trial should follow, a gold standard

Question 5

Purpose of consort?

Answer 5

purpose of consort is not to tell you how to conduct your trial, which is a mistake that sometimes reviewers make. It’s actually to serve as a guideline for writers, to tell them what information needs to be included in their paper, so that readers can make a decision about how much stock they’re going to put in the results.

Question 6

Extension of CONSORT- design

Answer 6

cluster trials
non-inferiority designs and equivalency designs
pragmatic trials

Question 7

Extension of CONSORT-intervention

Answer 7

herbal medicine intervention
non pharamcological intervention
acupuncture intervention

Question 8

Extension of CONSORT-Data?

Answer 8

Harms

Abstracts

Question 9

Title of Report

Answer 9

succinct
key designs terms
disease or population studied

Question 10

strucuture of abstract?

Answer 10

design, methods, results, conclusion

Question 11

structure of introduction section?

Answer 11

background
rationale
establish equipoise
ideally include a sistematic review
objectives/hypothesis

Question 12

What shoud be in methods-part 1?

Answer 12

IRB review and approvals
trial design, allocation ration
eligibility criteria (explicitely defined)
setting and location of a trial
intervetion (detailed enough to allow replication)
outcomes
sample size (how determined, interim analysis)
important changes during a trial

Question 13

What shoud be in methods-part 2?

Answer 13

randomization
allocation concealment
implementation of radnomization
masking
statistical methods

Question 14

structure of Consort diagramm?

Answer 14

enrolement
allocation
follow up
analysis

Question 15

results section according do consort?

Answer 15

diagramm
dates conducted, why trial ended
baseline data ( baseline data that describes the demographic and the clinical characteristics of the population, and that gives us an idea of the generalized ability and also. It allows us to compare groups and see whether there are any imbalances.)

estimates of outcomes, uncertainity (standard error, standard deviations or confidence variables.)

Question 16

consortt-tables and figures?

Answer 16

provide numerator and denumerator
colums are treatment comparisons
for aesthetics and easy reading, decimal align tables

Question 17

consort- table 1?

Answer 17

• baseline characteristics of a treatment group
• p values (could be couse of randomization, measure of potential confouning,
• standard deviation (prefferd over standard eror)
• decimal align tables
• whole number do not need decimal digits

Question 18

consort- discussion section?

Answer 18

interpretation (hypothesis conlusion, key results(not all results)), limitations (source of bioas, inprecision)
Authors should also discuss whether or not they believe that there is an appropriate balance of benefit and harms.
Generazibility

Question 19

consort- other info?

Answer 19

registration of trial
protocol- where it can be accessed
funding, role of funders