the composite (in this context)

English translation: composite endpoint

11:51 Jul 29, 2007
English to English translations [PRO]
Medical - Medical: Cardiology
English term or phrase: the composite (in this context)
The primary endpoint was the occurrence of the composite of an occluded infarct-related artery on the predischarge angiogram, or death or recurrent MI before coronary angiography.
What does "the composite" mean in this context? Does it mean "combination" or something else? Help me, please!
GEKAMON
English translation:composite endpoint
Explanation:
The text is poorly worded. What it means is that the study uses a composite endpoint - in other words, several single endpoints are valid - in this case either of the three stated endpoints, but obviously a combination is not required (or even possible!).

http://www.actmagazine.com/appliedclinicaltrials/article/art...

A composite endpoint in a RCT consists of multiple single endpoints that are combined in order to confront an investigational drug with a higher number of events expected during the trial. For instance, the primary composite endpoint may include mortality along with nonfatal endpoints such as hospitalization and cardiac arrest in chronic heart failure patients,6 or along with myocardial infarction and stroke in hypertensives.7

The major advantages in using a composite endpoint are: statistical precision and efficiency will be increased8 ; trials become smaller, less costly; and the results of promising new treatments will be available earlier. If more than one outcome is important for efficacy evaluation, a composite endpoint can efficiently deal with the issue of multiplicity.9 A summary measure for drug efficacy can be defined10 (e.g., the assessment of skeletal-related events [SREs] in trials for prevention or treatment of bone metastases).

Selected response from:

Dr Sue Levy (X)
Local time: 14:16
Grading comment
Thank you!!!!
4 KudoZ points were awarded for this answer



Summary of answers provided
5 +1composite endpoint
Dr Sue Levy (X)
3 +1possible interpretation
Ken Cox
3 +1sum
Alexander Vorobyev


Discussion entries: 4





  

Answers


53 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +1
sum


Explanation:
I suppose that in terms of this protocol the importance of all the listed events is equal. The primary endpoint will be the sum of incidence rates of A, B and C.
A-occluded infarct-related artery on the predischarge angiogram, B-death
C-recurrent MI before coronary angiography

Alexander Vorobyev
Local time: 15:16
Specializes in field
Native speaker of: Native in RussianRussian

Peer comments on this answer (and responses from the answerer)
agree  Ken Cox: could well be: resulting from the combined effects of three independent events (hence the 'or' in 'composite of ... or' -- but it's a bit telegrahic)
15 mins
  -> Thanks, Ken!
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55 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +1
possible interpretation


Explanation:
The endpoint was primarily determined by an occluded infarct-related artery on the predischarge angiogram, death, or recurrent MI before coronary angiography.

IMO these conditions are independent, so 'composite' or 'combination' is inappropriate. What the author probably had in mind is that these events formed the 'primary group' of endpoints (or endpoint-determining events).

Ken Cox
Local time: 14:16
Native speaker of: Native in EnglishEnglish
PRO pts in category: 4

Peer comments on this answer (and responses from the answerer)
agree  Dr Sue Levy (X): yes I agree it's not a combination of these three things - I see what the author meant though - the primary endpoint is not a single event
1 hr
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5 hrs   confidence: Answerer confidence 5/5 peer agreement (net): +1
composite endpoint


Explanation:
The text is poorly worded. What it means is that the study uses a composite endpoint - in other words, several single endpoints are valid - in this case either of the three stated endpoints, but obviously a combination is not required (or even possible!).

http://www.actmagazine.com/appliedclinicaltrials/article/art...

A composite endpoint in a RCT consists of multiple single endpoints that are combined in order to confront an investigational drug with a higher number of events expected during the trial. For instance, the primary composite endpoint may include mortality along with nonfatal endpoints such as hospitalization and cardiac arrest in chronic heart failure patients,6 or along with myocardial infarction and stroke in hypertensives.7

The major advantages in using a composite endpoint are: statistical precision and efficiency will be increased8 ; trials become smaller, less costly; and the results of promising new treatments will be available earlier. If more than one outcome is important for efficacy evaluation, a composite endpoint can efficiently deal with the issue of multiplicity.9 A summary measure for drug efficacy can be defined10 (e.g., the assessment of skeletal-related events [SREs] in trials for prevention or treatment of bone metastases).



Dr Sue Levy (X)
Local time: 14:16
Specializes in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 12
Grading comment
Thank you!!!!

Peer comments on this answer (and responses from the answerer)
agree  Elena Aleksandrova
1 hr

neutral  Ken Cox: thanks for clearing that up :-)
3 hrs
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