Talk:Randomized controlled trial/Draft: Difference between revisions

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== Recruitment? ==
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 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==
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
Except for this issue, I think the article is excellent and I'm happy to support approval.12:15, 28 April 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)
::Thanks, added my name to To approve. Well done Robert[[User:Gareth Leng|Gareth Leng]] 08:25, 7 May 2009 (UTC)
==Inappropriate use of RCTs==
I realise the following pertains mostly (but not entirely) to a small minority of all randomised trials, but I still think these negatives need to be mentioned.
There are some things missing from the ethical issues, and also some limitations of RCTs that need to be discussed.
Randomized Controlled Trials are, by their very nature, known to give false positives at a predictable rate. This is exploited by unscrupulous organisations and individuals wishing to promote therapies that are ineffective. RCTs also can't give a definitive negative, so when an effect is not shown the study can simply call for further testing and larger studies.
This is a problem with drug companies, who can keep testing things until they pass, but it is even more of a problem with Spiritual, Complimentary, and Alternative Medicine (or SCAM for short). Scammers have been exploiting RCTs these days in an attempt to add legitimacy to scientifically impossible and otherwise unjustifiable therapies.
There is also an issue kind of like data-mining. If you test a therapy against 20 slightly different diseases, you are practically guaranteed that one of those 20 tests will be a false positive. This leads scammers to test a supposedly universal therapy that they support against everything they can think of, and then when they find one that tests positive they will loudly proclaim there universal therapy has been proven.
The reason RCTs have these problems is that there is no science, or understanding of the biological method of action, involved anywhere in the process. RCTs rely purely on random chance.
This also makes RCTs easy targets for outright fraud. In other methods of doing science fraud is impossible, since to be correct one has to be logical, and simple thought experiments can check any proposition. But as long as a fraudster knows enough statistics to generate mathematically consistent fake data, they can claim anything with nobody the wiser.
There is also the moral issue of testing things that have already been disproven by the laws of science billions of times over. Since tests on humans are dangerous, expensive, inconvenient, and technically illegal under war crimes legislation when there is no pressing need for them, some RCTs are highly unethical.
There's also the issue that "informed consent" in the case of scientific absurdities is never given, even though it is required. They can't say that the test has no benefits to anyone and is trying to prove something impossible and already disproven. And ethics boards never require them to say so.
Also RCTs have become kind of a religion for many people in medicine, which blinds people to scientific absurdities. For example the Cochrane Library of Systematic Reviews proudly states that magical potions made by diluting poisons until none of the original atoms remain, whilst magically shaking them, are effective against some diseases. And no amount of scientific reasoning with them will convince them to remove the insanity. Other websites and organisations also blindly follow the Cochrane Library and refuse to remove insanity regardless of evidence. Oh, and they don't understand that the word "evidence" doesn't just mean RCTs, and that their peers in other scientific fields have evidence, and even hard proof, without the need for RCTs.
The conclusions one can make from an RCT are also extremely limited. For that exact combination of elements you get either an almost certain "yes that precise combination works", or you get an "I don't know, we need more testing". Without looking at the science behind it, there is no possible way to generalise from the results. So if you want to make even the slightest change, you need to test everything all over again. That doesn't stop people from drawing, or proclaiming, unsupported broad conclusions from the tests though.
There's also the issues of what consitutes a placebo. Whilst it is quite simple to come up with a placebo when testing chemicals for their chemical properties, other things, like surgery, acupuncture, magical spells, etc. don't have clear established placebos and often use inappropriate ones. Studies of supposedly magical remedies can't use a regular placebo or they would be comparing placebos against placebos. For them a placebo would be something proven to be chemically identical, yet having undergone whatever "magical" process it is they are testing (ie change nothing but what you are testing), yet they never, ever, make the slightest attempt to prove that it is a real placebo.
And of course there is the issue that since the testing process makes use of the rules of science and mathematics, one has to assume those rules are true in order to test something. Thus the process can't be used to test the proposition that the laws of science and mathematics are all wrong (like homeopaths and other idiots are arguing) for "magical" treatments.
So more coverage of the drawbacks of RCTs and when they are inappropriate would be good. The article already makes some mention of the steps required before an RCT is appropriate, but it could be spelled out better.
Don't get me wrong, I love statistics, and I love Randomised Controlled Trials and the Cochrane Library and medical research. But it has both advantages and limitations that need to be spelled out. [[User:Carl Kenner|Carl Kenner]] 20:38, 10 May 2009 (UTC)
==APPROVED Version 1.0==
<div class="usermessage plainlinks">Discussion for Approved [http://en.citizendium.org/wiki?title=Randomized_controlled_trial&oldid=100480853 Version 1.0] stopped here. Please continue further discussion under this break. </div>
Congratulations to everyone who worked on this article -- it has now been approved! [[User:Hayford Peirce|Hayford Peirce]] 18:49, 12 May 2009 (UTC)


== Toward Approval of Version 1.1 ==
== Toward Approval of Version 1.1 ==
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Other than that I think it's a great article. --[[User:David Yamakuchi|David Yamakuchi]] 00:38, 11 July 2011 (UTC)
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|call}} ==
== Approval Process: {{ApprovalProcess|certify}} ==


''Call for review: ''[[User:Peter Schmitt|Peter Schmitt]] 00:59, 16 September 2011 (UTC)
''Call for review: ''[[User:Peter Schmitt|Peter Schmitt]] 00:59, 16 September 2011 (UTC)


''Call for Approval: ''
''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)


''Approval Notice: ''


''Certification of Approval: ''
''Certification of Approval: ''[[User:Anthony.Sebastian|Anthony.Sebastian]] 12:46, 20 February 2012 (UTC)


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=== Comments ===
=== Comments ===
This has long been nominated for reapproval. --[[User:Peter Schmitt|Peter Schmitt]] 01:01, 16 September 2011 (UTC)
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

This article has a Citable Version.
 Main Article
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To learn how to update the categories for this article, see here. To update categories, edit the metadata template.
 Definition:  Method used to ensure objectivity when testing medical treatments. [d] [e]
Checklist and Archives
 Workgroup category:  Health Sciences [Editors asked to check categories]
 Talk Archive:  1  English language variant:  American English

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

Discussion for Approved Version 1.1 stopped here. Please continue further discussion under this break.

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

Discussion for Approved Version 1.2 stopped here. Please continue further discussion under this break.

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.   
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