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baseline visit

English translation: explanation below

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14:45 Mar 1, 2005
English to English translations [PRO]
Other
English term or phrase: baseline visit
To screen a patient, press 1.

To record a patient baseline visit, press 3.

To record a patient status change, press 4.

To perform a patient unblinding, press 6.

To change your PIN press 7.

What is the meaning of
baseline visit and patient unblinding.
chopra_2002
India
Local time: 03:58
English translation:explanation below
Explanation:
"The current definition of "Baseline Assessment" is confusing. We would suggest that you distinguish between "assessment" and "visit". Then:
The Screening Visit is the visit at which subjects are assessed as they enter (enrol in) a trial; the Baseline Visit is typically the visit immediately before subjects receive blinded or open-label study drug or treatment; the Baseline Assessment is the value of a variable used to describe the subject's condition immediately before the subject receives blinded or open label study drug or treatment (this is typically the value obtained at a Baseline Visit but can also be a combination of values obtained up to and including the Baseline Visit). "
http://www.cdisc.org/forum/default.asp

"Patient unblinding": In some clinical studies, the study medication given to the patients is "blinded", that is, the patient doesn't know whether he/she receives the drug or placebo (it can also be "double blind", when the doctor doesn't know, either). Unblinding: When the medication received by the patient is revealed. Sometimes also called "code-break".


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Note added at 18 mins (2005-03-01 15:03:17 GMT)
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The \"patient unblinding\" is usually done in a double-blind study when the condition of the patient deteriorates and the doctors need to know whether the patient has been receiving /her further treatment. When the treatment is \"unblinded\", the patient is usually withdrawn from the study.
\"Baseline\" in \"baseline visit\" is left in English in many languages.

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Note added at 20 mins (2005-03-01 15:05:21 GMT)
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Sorry - I was typing too quickly and accidentally deleted a few words from my sentence: ...whether the patient has been receiving the study drug or placebo (an inactive substance), in order to determine his/her further treatment.

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Note added at 33 mins (2005-03-01 15:18:59 GMT)
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If you decide to translate \"baseline\", be careful not to call it \"first study visit\" - the baseline visit precedes the first study visit (or week 1/month 1 visit).
Selected response from:

Elizabeth Rudin
United Kingdom
Local time: 23:28
Grading comment
Thanks to both of you for your wonderful help.
4 KudoZ points were awarded for this answer



Summary of answers provided
5 +5explanation belowElizabeth Rudin
3first visit ..
Nesrin


  

Answers


4 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5
first visit ..


Explanation:
The visit in which the patient's condition was first assessed (before he/she had received any treatment)...

..would be my understanding.

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Note added at 7 mins (2005-03-01 14:52:06 GMT)
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the Baseline Visit is typically the visit immediately before subjects receive blinded or open-label study drug or treatment; the Baseline > Assessment is the ...
www.cdisc.org/forum/b.asp?m=655

The \"baseline\" visit is the date of the first
in-person visit by the participant to the DILIN clinical site. ...
dilin.dcri.duke.edu/researchers/prospect/pro.html

Can\'t help with \"patient unblinding\", sorry. Maybe you should post that in a separate question.

Nesrin
Local time: 23:28
Native speaker of: Arabic
PRO pts in category: 28
Login to enter a peer comment (or grade)

13 mins   confidence: Answerer confidence 5/5 peer agreement (net): +5
explanation below


Explanation:
"The current definition of "Baseline Assessment" is confusing. We would suggest that you distinguish between "assessment" and "visit". Then:
The Screening Visit is the visit at which subjects are assessed as they enter (enrol in) a trial; the Baseline Visit is typically the visit immediately before subjects receive blinded or open-label study drug or treatment; the Baseline Assessment is the value of a variable used to describe the subject's condition immediately before the subject receives blinded or open label study drug or treatment (this is typically the value obtained at a Baseline Visit but can also be a combination of values obtained up to and including the Baseline Visit). "
http://www.cdisc.org/forum/default.asp

"Patient unblinding": In some clinical studies, the study medication given to the patients is "blinded", that is, the patient doesn't know whether he/she receives the drug or placebo (it can also be "double blind", when the doctor doesn't know, either). Unblinding: When the medication received by the patient is revealed. Sometimes also called "code-break".


--------------------------------------------------
Note added at 18 mins (2005-03-01 15:03:17 GMT)
--------------------------------------------------

The \"patient unblinding\" is usually done in a double-blind study when the condition of the patient deteriorates and the doctors need to know whether the patient has been receiving /her further treatment. When the treatment is \"unblinded\", the patient is usually withdrawn from the study.
\"Baseline\" in \"baseline visit\" is left in English in many languages.

--------------------------------------------------
Note added at 20 mins (2005-03-01 15:05:21 GMT)
--------------------------------------------------

Sorry - I was typing too quickly and accidentally deleted a few words from my sentence: ...whether the patient has been receiving the study drug or placebo (an inactive substance), in order to determine his/her further treatment.

--------------------------------------------------
Note added at 33 mins (2005-03-01 15:18:59 GMT)
--------------------------------------------------

If you decide to translate \"baseline\", be careful not to call it \"first study visit\" - the baseline visit precedes the first study visit (or week 1/month 1 visit).

Elizabeth Rudin
United Kingdom
Local time: 23:28
Native speaker of: Native in HungarianHungarian, Native in RomanianRomanian
PRO pts in category: 12
Grading comment
Thanks to both of you for your wonderful help.

Peer comments on this answer (and responses from the answerer)
agree  James Girard: Well explained!
15 mins
  -> thank you!

agree  Jonathan MacKerron
56 mins
  -> thank you!

agree  juvera
1 hr
  -> thank you!

agree  Balaban Cerit
2 hrs
  -> thank you!

agree  Craft.Content
9 hrs
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