Talk:Randomized controlled trial/Draft: Difference between revisions

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== Recruitment? ==
== Toward Approval of Version 1.1 ==


I wonder if this needs some detail on ethical recruitment, certainly the level in the [[Declaration of Helsinki]], and perhaps examples from 21CFR11 U.S. regulations. The role of an [[Institutional Review Board]] probably should be considered. [[User:Howard C. Berkowitz|Howard C. Berkowitz]] 00:38, 19 April 2009 (UTC)
I see that the pointer on this ToApprove template points to the current Approved version of the article and I assume that it is meant for the latest version of the Draft which made it's last edits on June 18, 2009 by Robert.  I also see that Gareth and Supten added their endorsement on June 19th and 20th which I also assume means that they saw the last two edits that were made after June 1, 2009 which is the date on the template. Considering that Robert made the editors, it looks like we have three edits that agree the current version, so unless there is any objection here tomorrow, we'll follow through with the process. If there is a problem, leave a note here and we'll check before we approve. Thanks, [[User:D. Matt Innis|D. Matt Innis]] 02:52, 1 July 2009 (UTC)
:I think some of this would help, I do not know this area as well though. Ok to add to later editions? [[User:Robert Badgett|Robert Badgett]] 01:38, 29 April 2009 (UTC)


==Publication bias==
==APPROVED [http://en.citizendium.org/wiki?title=Randomized_controlled_trial/Draft&oldid=100515524 Version 1.1]==  


Publication bias refers to the tendency that trials that show a positive significant effect are more likely to be published than those that show no effect or are inconclusive. The Merck affair is ''not'' a case of publication bias, but raises different but interesting issues. The core issue here is related to the predetermined schedule of the trial. For statistical rigor, it is important that the parameters of a trial, including the end date, be predetermined - it cannot be left open to the organisers when they choose to end the trial because of the natural temptation to stop the trial at a point when the results appear consistent with a hoped for outcome. The dispute in the Merck case arose because of adverse events that occurred ''after'' the prescheduled end date, and so were not included. The authors argued that to do so would invalidate the prospective statistical design; the objections were that the publication should have disclosed adverse events known to have occurred subsequently. The arguments though are complex
<div class="usermessage plainlinks">Discussion for Approved [http://en.citizendium.org/wiki?title=Randomized_controlled_trial/Draft&oldid=100515524 Version 1.1] stopped here. Please continue further discussion under this break. </div>


Except for this issue, I think the article is excellent and I'm happy to support approval.12:15, 28 April 2009 (UTC)
==New version ready - difficulties with draft/approved system==
I would like to submit the current version as the new approved version. I think I am learning that the method of using drafts is awkward because the public version is always out-of-date. If we had all the money and resources in the world, I would like to see CZ explore replacing the draft/approved system with a single version that displays trust metrics. See http://www.mememoir.org/ and a proposal at http://www.wikigenes.org/app/info/movie.html. - [[User:Robert Badgett|Robert Badgett]] 21:26, 14 August 2009 (UTC)


:I saw Merck as a variation of publication bias in that Merck suppressed negative data. However, I see your point. I removed this statement and replaced it with your first sentence above - which is succinctly worded. ok? - [[User:Robert Badgett|Robert Badgett]] 01:31, 29 April 2009 (UTC)
== approval ready ==


::Thanks, added my name to To approve. Well done Robert[[User:Gareth Leng|Gareth Leng]] 08:25, 7 May 2009 (UTC)
We have three editors on board, now.  That means we're ready to go.  If the approving editors prefer, the target date for approval may be moved up.  This one was set for extra long in advance so that we could be sure we'd have time to get all three editors arranged.  --Joe ([[User:Approvals Manager|Approvals Manager]]) 18:11, 5 October 2009 (UTC)
 
: An article about randomized trials should also point out the connection to its theoretical background from mathematical statistics. I have added three topics to the ralated topics list (it could probably be more), but it should be included in the main page, too, in some form. [[User:Peter Schmitt|Peter Schmitt]] 23:44, 23 October 2009 (UTC)
: The definition is '''much''' too long -- remember its use (related pages) and the guidelines!
: [[User:Peter Schmitt|Peter Schmitt]] 23:44, 23 October 2009 (UTC)
 
 
==APPROVED Version 1.2==
 
<div class="usermessage plainlinks">Discussion for Approved [http://en.citizendium.org/wiki?title=Randomized_controlled_trial/Draft&oldid=100580271 Version 1.2] stopped here. Please continue further discussion under this break. </div>
 
==Need to approve again==
Can we approve the many changes? I do not recall the procedure for this. - [[User:Robert Badgett|Robert Badgett]] 16:35, 25 January 2011 (UTC)
 
:Yes, Robert, we can.  Anthony has signed on, but since you made most of the edits, we'll need one more editor to sign on for approval.  DOn't forget to put a date in the metadata template to let me know when the time comes. [[User:D. Matt Innis|D. Matt Innis]] 02:03, 7 June 2011 (UTC)
 
Hi guys, sorry to butt in here...but...At the end of the intro the last sentence reads: If the experimental treatment is strikingly better than the control arm, ...and then just stops.
 
I'm not sure where the rest of the sentence went, but you should probably find it before approving...imho. 
 
Also, I think I saw some typos...so I will now change them.  Sorry if I inadvertently made something incorrect...this subject is some pretty thick stuff....just trying to help.
 
Other than that I think it's a great article. --[[User:David Yamakuchi|David Yamakuchi]] 00:38, 11 July 2011 (UTC)
 
==Merging two versions of Draft==
I've merged two versions of the Draft page.  There was only a two edit difference, but if something seems to be missing, let me know.  It did not go as smoothly as it should have, but I can't tell if it is a cache issue that will correct itself soon. [[User:D. Matt Innis|D. Matt Innis]] 03:05, 23 December 2011 (UTC)
: I have restored the most recent version. It was "covered" by the old (/draft) version due to the move. --[[User:Peter Schmitt|Peter Schmitt]] 11:19, 23 December 2011 (UTC)
 
== Approval Process: {{ApprovalProcess|certify}} ==
 
''Call for review: ''[[User:Peter Schmitt|Peter Schmitt]] 00:59, 16 September 2011 (UTC)
 
''Call for Approval: ''[[User:Peter Schmitt|Peter Schmitt]] 11:32, 23 December 2011 (UTC)
 
''Approval Notice: '' Revision [http://en.citizendium.org/wiki?title=Randomized_controlled_trial/Draft&oldid=100795368 04:39, 26 January 2012]
: Final Approval set for Feb 20, 2012.  [[User:Anthony.Sebastian|Anthony.Sebastian]] 02:58, 13 February 2012 (UTC)
 
 
''Certification of Approval: ''[[User:Anthony.Sebastian|Anthony.Sebastian]] 12:46, 20 February 2012 (UTC)
 
----
''Please discuss the article below, [[{{BASEPAGENAME}}/Approval]] is for brief official referee's only!''
=== Comments ===
This has long been nominated for reapproval. --[[User:Peter Schmitt|Peter Schmitt]] 01:01, 16 September 2011 (UTC)
:You can add another three months to the above comment. I thought we had an Approvals Manager or something? [[User:David Finn|David Finn]] 07:30, 13 December 2011 (UTC)
 
:: See also the comments in the section [[#Need to approve again]] above. The incomplete sentence is in the approved version, too. --[[User:Peter Schmitt|Peter Schmitt]] 11:36, 23 December 2011 (UTC)
 
+++++
 
Final Approval set for Feb 20, 2012, allowing one more week for any needed revisions.  [[User:Anthony.Sebastian|Anthony.Sebastian]] 02:58, 13 February 2012 (UTC)
 
=== Remark ===
In a personal email I was criticised for signing my comment (on the /Approval subpage) by adding "Secretary of the EC" to my signature.
I did so because by [http://ec.citizendium.org/wiki/EC:R-2011-027 EC:R-2011-027] (C.1) the Secretary of the EC
is involved in the ''management'' of the approval process ('''not''' in the final ''certification'' of the approval).
Moreover, I have only stated facts and drawn a conclusion.
It is in agreement with Anthony that, since this process is new, I help with the process.
--[[User:Peter Schmitt|Peter Schmitt]] 17:42, 15 February 2012 (UTC)
 
:I appreciate the EC Secretary's guidance and assistance, as having only been recently appointed Co-Approval_Manager, I am new to the process.  [[User:Anthony.Sebastian|Anthony.Sebastian]] 04:32, 16 February 2012 (UTC)
 
::Just as a point of order (and I am not sure that the new rules were meant for this purpose), but I have completed the article mechanics even though it looks like Anthony is acting as the Approval Manager on his own article.  Since we have two other editors, it probably isn't that important. [[User:D. Matt Innis|D. Matt Innis]] 18:06, 24 February 2012 (UTC)
 
:::Matt, thanks.  This was long overdue.  My input on this article was minimal, too little to be characterized as "his own article". I appreciate any caveats you have for future articles I certify for approval, because the green is prominent behind my ears.  [[User:Anthony.Sebastian|Anthony.Sebastian]] 17:21, 25 February 2012 (UTC)
 
::::Absolutely, Anthony, that's the way I saw it, too.  I think the important thing is that we have three editors approving it; the spirit and intent of the rule was to keep people from Approving their own article (without collaborative input).  There is plenty of collaboration here, and, especially, little disagreement or controversy. Sometimes the more complicated we make the rules to avoid approval of biased articles, the more difficult we make the approval of the obviously neutrally written articles.
 
::::The rules have changed some, but I'll be glad to help any way that I can.
::::[[User:D. Matt Innis|D. Matt Innis]] 17:36, 25 February 2012 (UTC)
 
:::::Matt, regarding draft articles for which I am neither Editor in any of the draft's Workgroup categories nor contributing author, may I, as Approvals Manager, be the first to nominate the draft, put up the ToApproval banner on the draft, then seek one or more Editors to support the nomination?  If so, we can start increasing the rates of approval/re-approval.
 
:::::I should think that okay, since, if I'm qualified to certify approval I should be equally qualified to nominate it for approval.  In both cases I would need to carefully review the article.  I would set the end-of-review date for at least two weeks after nomination and extend if necessary to find qualified Editors to support the nomination.
 
:::::I see it as a method to facilitate the approval process overall. Any thoughts about this?&nbsp;&nbsp;[[User:Anthony.Sebastian|Anthony.Sebastian]] 21:34, 25 February 2012 (UTC)
 
::::::Anthony, [http://ec.citizendium.org/wiki/EC:R-2011-027 EC:R-2011-027] seems to be saying exactly that.  The Approval Manager position, as directed by the EC, seems to have been granted powers (including nominating an article for approval--as any Citizen can nominate an article), that were not available to the previous Approval Manager position.  You might need to get clarification from the EC to determine if that was their intent, but as the constabulary, there is no reason not to act just as you describe. [[User:D. Matt Innis|D. Matt Innis]] 22:42, 25 February 2012 (UTC)
 
::::::Matt, re-reading [http://ec.citizendium.org/wiki/EC:R-2011-027 EC:R-2011-027] for the umpteenth time, my other self, that 98% of my brain I have no direct line with must have steered my course. Peter did not slap my hand when I recently nominated [[ASIMO]].  The challenge: finding appropriate Editors to support the nomination. &nbsp;&nbsp;

Latest revision as of 21:46, 25 February 2012

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Toward Approval of Version 1.1

I see that the pointer on this ToApprove template points to the current Approved version of the article and I assume that it is meant for the latest version of the Draft which made it's last edits on June 18, 2009 by Robert. I also see that Gareth and Supten added their endorsement on June 19th and 20th which I also assume means that they saw the last two edits that were made after June 1, 2009 which is the date on the template. Considering that Robert made the editors, it looks like we have three edits that agree the current version, so unless there is any objection here tomorrow, we'll follow through with the process. If there is a problem, leave a note here and we'll check before we approve. Thanks, D. Matt Innis 02:52, 1 July 2009 (UTC)

APPROVED Version 1.1

New version ready - difficulties with draft/approved system

I would like to submit the current version as the new approved version. I think I am learning that the method of using drafts is awkward because the public version is always out-of-date. If we had all the money and resources in the world, I would like to see CZ explore replacing the draft/approved system with a single version that displays trust metrics. See http://www.mememoir.org/ and a proposal at http://www.wikigenes.org/app/info/movie.html. - Robert Badgett 21:26, 14 August 2009 (UTC)

approval ready

We have three editors on board, now. That means we're ready to go. If the approving editors prefer, the target date for approval may be moved up. This one was set for extra long in advance so that we could be sure we'd have time to get all three editors arranged. --Joe (Approvals Manager) 18:11, 5 October 2009 (UTC)

An article about randomized trials should also point out the connection to its theoretical background from mathematical statistics. I have added three topics to the ralated topics list (it could probably be more), but it should be included in the main page, too, in some form. Peter Schmitt 23:44, 23 October 2009 (UTC)
The definition is much too long -- remember its use (related pages) and the guidelines!
Peter Schmitt 23:44, 23 October 2009 (UTC)


APPROVED Version 1.2

Need to approve again

Can we approve the many changes? I do not recall the procedure for this. - Robert Badgett 16:35, 25 January 2011 (UTC)

Yes, Robert, we can. Anthony has signed on, but since you made most of the edits, we'll need one more editor to sign on for approval. DOn't forget to put a date in the metadata template to let me know when the time comes. D. Matt Innis 02:03, 7 June 2011 (UTC)

Hi guys, sorry to butt in here...but...At the end of the intro the last sentence reads: If the experimental treatment is strikingly better than the control arm, ...and then just stops.

I'm not sure where the rest of the sentence went, but you should probably find it before approving...imho.

Also, I think I saw some typos...so I will now change them. Sorry if I inadvertently made something incorrect...this subject is some pretty thick stuff....just trying to help.

Other than that I think it's a great article. --David Yamakuchi 00:38, 11 July 2011 (UTC)

Merging two versions of Draft

I've merged two versions of the Draft page. There was only a two edit difference, but if something seems to be missing, let me know. It did not go as smoothly as it should have, but I can't tell if it is a cache issue that will correct itself soon. D. Matt Innis 03:05, 23 December 2011 (UTC)

I have restored the most recent version. It was "covered" by the old (/draft) version due to the move. --Peter Schmitt 11:19, 23 December 2011 (UTC)

Approval Process: Approval certified

Call for review: Peter Schmitt 00:59, 16 September 2011 (UTC)

Call for Approval: Peter Schmitt 11:32, 23 December 2011 (UTC)

Approval Notice: Revision 04:39, 26 January 2012

Final Approval set for Feb 20, 2012. Anthony.Sebastian 02:58, 13 February 2012 (UTC)


Certification of Approval: Anthony.Sebastian 12:46, 20 February 2012 (UTC)


Please discuss the article below, Randomized controlled trial/Approval is for brief official referee's only!

Comments

This has long been nominated for reapproval. --Peter Schmitt 01:01, 16 September 2011 (UTC)

You can add another three months to the above comment. I thought we had an Approvals Manager or something? David Finn 07:30, 13 December 2011 (UTC)
See also the comments in the section #Need to approve again above. The incomplete sentence is in the approved version, too. --Peter Schmitt 11:36, 23 December 2011 (UTC)

+++++

Final Approval set for Feb 20, 2012, allowing one more week for any needed revisions. Anthony.Sebastian 02:58, 13 February 2012 (UTC)

Remark

In a personal email I was criticised for signing my comment (on the /Approval subpage) by adding "Secretary of the EC" to my signature. I did so because by EC:R-2011-027 (C.1) the Secretary of the EC is involved in the management of the approval process (not in the final certification of the approval). Moreover, I have only stated facts and drawn a conclusion. It is in agreement with Anthony that, since this process is new, I help with the process. --Peter Schmitt 17:42, 15 February 2012 (UTC)

I appreciate the EC Secretary's guidance and assistance, as having only been recently appointed Co-Approval_Manager, I am new to the process. Anthony.Sebastian 04:32, 16 February 2012 (UTC)
Just as a point of order (and I am not sure that the new rules were meant for this purpose), but I have completed the article mechanics even though it looks like Anthony is acting as the Approval Manager on his own article. Since we have two other editors, it probably isn't that important. D. Matt Innis 18:06, 24 February 2012 (UTC)
Matt, thanks. This was long overdue. My input on this article was minimal, too little to be characterized as "his own article". I appreciate any caveats you have for future articles I certify for approval, because the green is prominent behind my ears. Anthony.Sebastian 17:21, 25 February 2012 (UTC)
Absolutely, Anthony, that's the way I saw it, too. I think the important thing is that we have three editors approving it; the spirit and intent of the rule was to keep people from Approving their own article (without collaborative input). There is plenty of collaboration here, and, especially, little disagreement or controversy. Sometimes the more complicated we make the rules to avoid approval of biased articles, the more difficult we make the approval of the obviously neutrally written articles.
The rules have changed some, but I'll be glad to help any way that I can.
D. Matt Innis 17:36, 25 February 2012 (UTC)
Matt, regarding draft articles for which I am neither Editor in any of the draft's Workgroup categories nor contributing author, may I, as Approvals Manager, be the first to nominate the draft, put up the ToApproval banner on the draft, then seek one or more Editors to support the nomination? If so, we can start increasing the rates of approval/re-approval.
I should think that okay, since, if I'm qualified to certify approval I should be equally qualified to nominate it for approval. In both cases I would need to carefully review the article. I would set the end-of-review date for at least two weeks after nomination and extend if necessary to find qualified Editors to support the nomination.
I see it as a method to facilitate the approval process overall. Any thoughts about this?  Anthony.Sebastian 21:34, 25 February 2012 (UTC)
Anthony, EC:R-2011-027 seems to be saying exactly that. The Approval Manager position, as directed by the EC, seems to have been granted powers (including nominating an article for approval--as any Citizen can nominate an article), that were not available to the previous Approval Manager position. You might need to get clarification from the EC to determine if that was their intent, but as the constabulary, there is no reason not to act just as you describe. D. Matt Innis 22:42, 25 February 2012 (UTC)
Matt, re-reading EC:R-2011-027 for the umpteenth time, my other self, that 98% of my brain I have no direct line with must have steered my course. Peter did not slap my hand when I recently nominated ASIMO. The challenge: finding appropriate Editors to support the nomination.