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EVIDENCE-BASED-HEALTH  June 2013

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Subject:

Re: EVIDENCE-BASED-HEALTH Digest - 4 Jun 2013 to 5 Jun 2013 (#2013-141)

From:

Matt Williams <[log in to unmask]>

Reply-To:

[log in to unmask]

Date:

Thu, 6 Jun 2013 06:58:23 +0000

Content-Type:

text/plain

Parts/Attachments:

Parts/Attachments

text/plain (1 lines)

Dear Jon,



My feeling would be to use (something like) the log of the study size. Alternatives would be square-root, etc. These would give you fewer values (few studies are > 10e6), and capture the fact that adding 100 pts to a trial has more of an impact if you already have 100 rather than 1000.



In theory, there should be an empirical basis for this - you might try relating it to the formula(e) used for sample size calculation, but I don't have those to hand. I've been meaning to look at this for ages, and have never got round to it.



Hope that's useful,

Matt

Sent from my BlackBerry® wireless device



-----Original Message-----

From:     EVIDENCE-BASED-HEALTH automatic digest system <[log in to unmask]>

Sender:   "Evidence based health (EBH)" <[log in to unmask]>

Date:     Thu, 6 Jun 2013 00:24:38 

To: <[log in to unmask]>

Reply-To: "Evidence based health (EBH)" <[log in to unmask]>

Subject: EVIDENCE-BASED-HEALTH Digest - 4 Jun 2013 to 5 Jun 2013 (#2013-141)



There are 10 messages totaling 2986 lines in this issue.



Topics of the day:



  1. Categorising the size of a clinical trial (10)



----------------------------------------------------------------------



Date:    Wed, 5 Jun 2013 17:10:31 +0100

From:    Jon Brassey <[log in to unmask]>

Subject: Categorising the size of a clinical trial



Hi All,



This is a strange question, but would welcome any advice.  I'm trying to

create a system to categorise the size of trials, based on the number of

participants.  I'm thinking it'd be something like very small, small,

medium, large and very large.



I could arbitrarily say something like:





   - very small trial = less than 20 patients

   - small = 21-99

   - medium = 100-499

   - large = 500-4999

   - very large = 5000+



But, is there already some work in this area?



BW



jon



-- 



Jon Brassey

Trip Database

http://www.tripdatabase.com

Find evidence fast



------------------------------



Date:    Wed, 5 Jun 2013 16:37:55 +0000

From:    "Dahm,Philipp" <[log in to unmask]>

Subject: Re: Categorising the size of a clinical trial



Hello Jon:



I am curious – what is your purpose for categorizing trials by sample size?



Ph*



Philipp Dahm, MD, MHSc, FACS

Professor of Urology, University of Florida

Coordinating Editor, Cochrane Prostatic Diseases & Urological Cancers Group

College of Medicine, Health Science Center

Box 100247, Room N2-15

Gainesville, FL 32610-0247

Phone:  (352) 273-8634

Fax: (352) 273-7515

Email: [log in to unmask]



From: Jon Brassey <[log in to unmask]<mailto:[log in to unmask]>>

Reply-To: Jon Brassey <[log in to unmask]<mailto:[log in to unmask]>>

Date: Wednesday, June 5, 2013 12:10 PM

To: Evidence health <[log in to unmask]<mailto:[log in to unmask]>>

Subject: Categorising the size of a clinical trial



Hi All,



This is a strange question, but would welcome any advice.  I'm trying to create a system to categorise the size of trials, based on the number of participants.  I'm thinking it'd be something like very small, small, medium, large and very large.



I could arbitrarily say something like:





  *   very small trial = less than 20 patients

  *   small = 21-99

  *   medium = 100-499

  *   large = 500-4999

  *   very large = 5000+



But, is there already some work in this area?



BW



jon



--



Jon Brassey

Trip Database

http://www.tripdatabase.com

Find evidence fast



------------------------------



Date:    Wed, 5 Jun 2013 09:47:27 -0700

From:    Paul Elias <[log in to unmask]>

Subject: Re: Categorising the size of a clinical trial



I have seen this in one study....

(<50 v small, 50-99 small, 

100-199 low medium, 200-499 medium, 

500-999 large, and ≥1000 patients very large).



     Best,Paul E. Alexander 





--- On Wed, 6/5/13, Dahm,Philipp <[log in to unmask]> wrote:



From: Dahm,Philipp <[log in to unmask]>

Subject: Re: Categorising the size of a clinical trial

To: [log in to unmask]

Received: Wednesday, June 5, 2013, 5:37 PM





 




Hello Jon:




I am curious – what is your purpose for categorizing trials by sample size?




Ph*







Philipp Dahm, MD, MHSc, FACS 


Professor of Urology, University of Florida

Coordinating Editor, Cochrane Prostatic Diseases & Urological Cancers Group

College of Medicine, Health Science Center 


Box 100247, Room N2-15 


Gainesville, FL 32610-0247 


Phone:  (352) 273-8634


Fax: (352) 273-7515


Email: [log in to unmask]










From: Jon Brassey <[log in to unmask]>


Reply-To: Jon Brassey <[log in to unmask]>


Date: Wednesday, June 5, 2013 12:10 PM


To: Evidence health <[log in to unmask]>


Subject: Categorising the size of a clinical trial









Hi All,
 
This is a strange question, but would welcome any advice.  I'm trying to create a system to categorise the size of trials, based on the number of participants.  I'm thinking it'd be something like very small, small, medium, large and very large.
 
I could arbitrarily say something like:
 

very small trial = less than 20 patientssmall = 21-99medium = 100-499large = 500-4999very large = 5000+ 
But, is there already some work in this area?
 
BW
 
jon
 
-- 
 
Jon Brassey
Trip Database
http://www.tripdatabase.com
Find evidence fast
 





------------------------------



Date:    Wed, 5 Jun 2013 16:53:32 +0000

From:    "Johnson, E Diane" <[log in to unmask]>

Subject: Re: Categorising the size of a clinical trial



Hi Jon, FWIW, Embase has some index terms/check tags related to study size, although I'm not sure whether they are consistently applied:



Major clinical study: Original items reporting clinical work on greater than 50 patients

Clinical article:  Original items reporting clinical work on 5-50 patients

Case Report:  Original items reporting clinical work on not more than 4 individual cases



See p. 13 in the 2012 Embase indexing guide:

http://www.google.com/url?sa=t&rct=j&q=embase%20%22major%20clinical%20study%22&source=web&cd=1&cad=rja&ved=0CD4QFjAA&url=http%3A%2F%2Fcdn.elsevier.com%2Fassets%2Fpdf_file%2F0009%2F126873%2FEmbase-indexing-guide-2012.pdf&ei=2mqvUc_JCYaJrgGAiIGIBg&usg=AFQjCNEB2elhlum5L-NAu67EnTn2rpOUyg&bvm=bv.47380653,d.aWM







E. Diane Johnson

Assistant Director, Information Services and Resources

J. Otto Lottes Health Sciences Library

Univ of Missouri

Columbia, MO 65212

573-882-6142

[log in to unmask]<mailto:[log in to unmask]>



Live Reference Available Weekdays from the Health Sciences Library Website!

http://healthlibrary.missouri.edu/contactus.cfm









From: Evidence based health (EBH) [mailto:[log in to unmask]] On Behalf Of Jon Brassey

Sent: Wednesday, June 05, 2013 11:11 AM

To: [log in to unmask]

Subject: Categorising the size of a clinical trial



Hi All,



This is a strange question, but would welcome any advice.  I'm trying to create a system to categorise the size of trials, based on the number of participants.  I'm thinking it'd be something like very small, small, medium, large and very large.



I could arbitrarily say something like:





  *   very small trial = less than 20 patients

  *   small = 21-99

  *   medium = 100-499

  *   large = 500-4999

  *   very large = 5000+

But, is there already some work in this area?



BW



jon



--



Jon Brassey

Trip Database

http://www.tripdatabase.com

Find evidence fast



------------------------------



Date:    Wed, 5 Jun 2013 14:03:55 -0400

From:    James Walker <[log in to unmask]>

Subject: Re: Categorising the size of a clinical trial



I'm wondering about the need for (and statistical wisdom of) translating a meaningful, computable value (the number of subjects) to a necessarily arbitrary set of categories--which users will have to remember how to translate back into an approximation of the original value.

Best regards.

On Jun 5, 2013, at 12:53 PM, "Johnson, E Diane" <[log in to unmask]> wrote:



> Hi Jon, FWIW, Embase has some index terms/check tags related to study size, although I’m not sure whether they are consistently applied: 

>  

> Major clinical study: Original items reporting clinical work on greater than 50 patients

> Clinical article:  Original items reporting clinical work on 5-50 patients

> Case Report:  Original items reporting clinical work on not more than 4 individual cases

>  

> See p. 13 in the 2012 Embase indexing guide: 

> http://www.google.com/url?sa=t&rct=j&q=embase%20%22major%20clinical%20study%22&source=web&cd=1&cad=rja&ved=0CD4QFjAA&url=http%3A%2F%2Fcdn.elsevier.com%2Fassets%2Fpdf_file%2F0009%2F126873%2FEmbase-indexing-guide-2012.pdf&ei=2mqvUc_JCYaJrgGAiIGIBg&usg=AFQjCNEB2elhlum5L-NAu67EnTn2rpOUyg&bvm=bv.47380653,d.aWM

>  

>  

>  

> E. Diane Johnson

> Assistant Director, Information Services and Resources

> J. Otto Lottes Health Sciences Library

> Univ of Missouri

> Columbia, MO 65212

> 573-882-6142

> [log in to unmask]

>  

> Live Reference Available Weekdays from the Health Sciences Library Website!

> http://healthlibrary.missouri.edu/contactus.cfm

>  

>  

>  

>  

> From: Evidence based health (EBH) [mailto:[log in to unmask]] On Behalf OfJon Brassey

> Sent: Wednesday, June 05, 2013 11:11 AM

> To: [log in to unmask]

> Subject: Categorising the size of a clinical trial

>  

> Hi All,

>  

> This is a strange question, but would welcome any advice.  I'm trying to create a system to categorise the size of trials, based on the number of participants.  I'm thinking it'd be something like very small, small, medium, large and very large.

>  

> I could arbitrarily say something like:

>  

> very small trial = less than 20 patients

> small = 21-99

> medium = 100-499

> large = 500-4999

> very large = 5000+

> But, is there already some work in this area?

>  

> BW

>  

> jon

>  

> --

>  

> Jon Brassey

> Trip Database

> http://www.tripdatabase.com

> Find evidence fast

>  



------------------------------



Date:    Wed, 5 Jun 2013 14:06:55 -0400

From:    "Ansari, Mohammed" <[log in to unmask]>

Subject: Re: Categorising the size of a clinical trial



Other determinants of what defines a study size are - effect size,

baseline risk/control event rates, and data dispersion. Size is relative

to what magnitude is being measured under what conditions.



 



See this paper in JCE, issue 64, 2011



 



GRADE guidelines 6. Rating the quality of evidence -- imprecision



 



 



 



From: Evidence based health (EBH)

[mailto:[log in to unmask]] On Behalf Of James Walker

Sent: Wednesday, June 05, 2013 2:04 PM

To: [log in to unmask]

Subject: Re: Categorising the size of a clinical trial



 



I'm wondering about the need for (and statistical wisdom of) translating

a meaningful, computable value (the number of subjects) to a necessarily

arbitrary set of categories--which users will have to remember how to

translate back into an approximation of the original value.



Best regards.



On Jun 5, 2013, at 12:53 PM, "Johnson, E Diane"

<[log in to unmask]> wrote:











Hi Jon, FWIW, Embase has some index terms/check tags related to study

size, although I'm not sure whether they are consistently applied: 



 



Major clinical study: Original items reporting clinical work on greater

than 50 patients



Clinical article:  Original items reporting clinical work on 5-50

patients



Case Report:  Original items reporting clinical work on not more than 4

individual cases



 



See p. 13 in the 2012 Embase indexing guide: 



http://www.google.com/url?sa=t&rct=j&q=embase%20%22major%20clinical%20st

udy%22&source=web&cd=1&cad=rja&ved=0CD4QFjAA&url=http%3A%2F%2Fcdn.elsevi

er.com%2Fassets%2Fpdf_file%2F0009%2F126873%2FEmbase-indexing-guide-2012.

pdf&ei=2mqvUc_JCYaJrgGAiIGIBg&usg=AFQjCNEB2elhlum5L-NAu67EnTn2rpOUyg&bvm

=bv.47380653,d.aWM

<http://www.google.com/url?sa=t&rct=j&q=embase%20%22major%20clinical%20s

tudy%22&source=web&cd=1&cad=rja&ved=0CD4QFjAA&url=http%3A%2F%2Fcdn.elsev

ier.com%2Fassets%2Fpdf_file%2F0009%2F126873%2FEmbase-indexing-guide-2012

.pdf&ei=2mqvUc_JCYaJrgGAiIGIBg&usg=AFQjCNEB2elhlum5L-NAu67EnTn2rpOUyg&bv

m=bv.47380653,d.aWM> 



 



 



 



E. Diane Johnson



Assistant Director, Information Services and Resources



J. Otto Lottes Health Sciences Library



Univ of Missouri



Columbia, MO 65212



573-882-6142



[log in to unmask] <mailto:[log in to unmask]> 



 



Live Reference Available Weekdays from the Health Sciences Library

Website!



http://healthlibrary.missouri.edu/contactus.cfm

<http://healthlibrary.missouri.edu/contactus.cfm> 



 



 



 



 



From: Evidence based health (EBH)

[mailto:[log in to unmask]] On Behalf OfJon Brassey

Sent: Wednesday, June 05, 2013 11:11 AM

To: [log in to unmask]

Subject: Categorising the size of a clinical trial



 



Hi All,



 



This is a strange question, but would welcome any advice.  I'm trying to

create a system to categorise the size of trials, based on the number of

participants.  I'm thinking it'd be something like very small, small,

medium, large and very large.



 



I could arbitrarily say something like:



 



*	very small trial = less than 20 patients

*	small = 21-99

*	medium = 100-499

*	large = 500-4999

*	very large = 5000+



But, is there already some work in this area?



 



BW



 



jon



 



--



 



Jon Brassey



Trip Database



http://www.tripdatabase.com <http://www.tripdatabase.com> 



Find evidence fast



 



 





--------------------

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Avis de confidentialité – Ce courriel, y compris ses pièces jointes, s’adresse au destinataire uniquement et pourrait contenir des renseignements confidentiels. Si vous n’êtes pas le bon destinataire, il est strictement interdit de lire, d’utiliser, de divulguer, de copier ou de diffuser ce courriel ou son contenu, en partie ou en entier. Si vous avez reçu ce courriel par erreur, veuillez en informer immédiatement l’expéditeur ou le bureau de la Protection des renseignements personnels ([log in to unmask]), puis effacez le courriel ainsi que les pièces jointes et toute autre copie. Merci.

--------------------



------------------------------



Date:    Wed, 5 Jun 2013 21:38:26 +0330

From:    Farhad Shokraneh <[log in to unmask]>

Subject: Re: Categorising the size of a clinical trial



Dear Jon,



I think the terms small and large might not be same for all disease. For

instance a clinical trial including 20 patients with a rare

condition/disease still is large. Despite this, I suggest *Phases

*(encompassing

the terms large/small) of clinical trials as used in PubMed (Article Types)

or clinicaltrials <http://www.nlm.nih.gov/services/ctphases.html>. Also,

Wikipedia <http://en.wikipedia.org/wiki/Clinical_trial#Phases> has

mentioned number of participants in each phase but I couldn't find its

Reference.



I have the as same question as Philipp's. Is this about new upgrades of

TRIP?



Bests,

Farhad







On Wed, Jun 5, 2013 at 7:40 PM, Jon Brassey <[log in to unmask]>wrote:



> Hi All,

>

> This is a strange question, but would welcome any advice.  I'm trying to

> create a system to categorise the size of trials, based on the number of

> participants.  I'm thinking it'd be something like very small, small,

> medium, large and very large.

>

> I could arbitrarily say something like:

>

>

>    - very small trial = less than 20 patients

>    - small = 21-99

>    - medium = 100-499

>    - large = 500-4999

>    - very large = 5000+

>

> But, is there already some work in this area?

>

> BW

>

> jon

>

> --

>

> Jon Brassey

> Trip Database

> http://www.tripdatabase.com

> Find evidence fast

>

>







-- 

*Farhad Shokraneh*, BSc, MS, MedLIS



Iranian Center for Evidence-Based Medicine,

Tabriz University of Medical Sciences, Tabriz, Iran

Cell Phone: +98 (0) 9149567734

Google Scholar Profile<http://scholar.google.com/citations?hl=en&user=bpljzVEAAAAJ&view_op=list_works&pagesize=100>

ResearchGate Profile<https://www.researchgate.net/profile/Farhad_Shokraneh/>



------------------------------



Date:    Wed, 5 Jun 2013 20:17:27 +0200

From:    Tom Jefferson <[log in to unmask]>

Subject: Re: Categorising the size of a clinical trial



Very interesting discussion. As Mohammed suggest, it revolves around what

you mean by size.



If it's denominator, which denominator?



And: according to the publication or the CSR? (That is if you know there

have been one or more trials of course)



Thank you, guys: very stimulating.



Tom.



On 5 June 2013 20:08, Farhad Shokraneh <[log in to unmask]> wrote:



> Dear Jon,

>

> I think the terms small and large might not be same for all disease. For

> instance a clinical trial including 20 patients with a rare

> condition/disease still is large. Despite this, I suggest *Phases *(encompassing

> the terms large/small) of clinical trials as used in PubMed (Article Types)

> or clinicaltrials <http://www.nlm.nih.gov/services/ctphases.html>. Also,

> Wikipedia <http://en.wikipedia.org/wiki/Clinical_trial#Phases> has

> mentioned number of participants in each phase but I couldn't find its

> Reference.

>

> I have the as same question as Philipp's. Is this about new upgrades of

> TRIP?

>

> Bests,

> Farhad

>

>

>

> On Wed, Jun 5, 2013 at 7:40 PM, Jon Brassey <[log in to unmask]>wrote:

>

>> Hi All,

>>

>> This is a strange question, but would welcome any advice.  I'm trying to

>> create a system to categorise the size of trials, based on the number of

>> participants.  I'm thinking it'd be something like very small, small,

>> medium, large and very large.

>>

>> I could arbitrarily say something like:

>>

>>

>>    - very small trial = less than 20 patients

>>    - small = 21-99

>>    - medium = 100-499

>>    - large = 500-4999

>>    - very large = 5000+

>>

>> But, is there already some work in this area?

>>

>> BW

>>

>> jon

>>

>> --

>>

>> Jon Brassey

>> Trip Database

>> http://www.tripdatabase.com

>> Find evidence fast

>>

>>

>

>

>

> --

> *Farhad Shokraneh*, BSc, MS, MedLIS

>

> Iranian Center for Evidence-Based Medicine,

> Tabriz University of Medical Sciences, Tabriz, Iran

> Cell Phone: +98 (0) 9149567734

> Google Scholar Profile<http://scholar.google.com/citations?hl=en&user=bpljzVEAAAAJ&view_op=list_works&pagesize=100>

> ResearchGate Profile<https://www.researchgate.net/profile/Farhad_Shokraneh/>

>







-- 

Dr Tom Jefferson

Medico Chirurgo

GMC # 2527527

www.attentiallebufale.it



------------------------------



Date:    Wed, 5 Jun 2013 20:12:18 +0000

From:    Juan Acuna <[log in to unmask]>

Subject: Re: Categorising the size of a clinical trial



Hi all,

Interesting discussion. Thanks for sharing.

I think two issues are being mixed here:





1.       The "absolute" size of the trial (number of subjects).



2.       The sample size.



Several comments addressed the first one and I see of not a dramatic importance to classify a study (whether a trial or not) according to its size, unless such classification is required for specific purposes (such as database classification, etc.).



Of more relevance and importance is that the size of the sample is probably related to both the internal and external validity of a given study thus, related to the quality of the study.



Sample size (SS) is determined (simplistically speaking) by the level of significance set for the study (the size of the random error that we need to account for, and the numerator of the SS formula) and the size of the effect that the study wants to detect (and in essence, the denominator in the SS formula). The consequence of considering these elements in the context on the absolute size (number of subjects in the study) is that given the right conditions, a small SS could be appropriate. In other words, and relevant to the SS, a small study could be a good and valid study. In inadequate conditions, even a large sample size could threaten the internal validity (and external validity) of a study. In other simpler words, a large study could be a bad study.



Conclusion: absolute size of a study and quality (as it relates to the SS) are neither equivalent nor always related.



I hope this helps.

JA



Juan M. Acuña M.D., MSc., FACOG.

FIU Assistant Vice-President for Clinical and Community Research

Associate Professor of Human and Molecular Genetics and Clinical Epidemiology,

FIU Herbert Wertheim College of Medicine



Director, Division of Research and Information

And Data Coordinating Center

Florida International University

Herbert Wertheim College  of Medicine



Guest Researcher, Division of Reproductive Health

Centers for Disease Control and Prevention



11200 SW 8th Street

AHC2-474

Miami, FL 33199

Ph (305) 348-0676







From: Evidence based health (EBH) [mailto:[log in to unmask]] On Behalf Of Farhad Shokraneh

Sent: Wednesday, June 05, 2013 2:08 PM

To: [log in to unmask]

Subject: Re: Categorising the size of a clinical trial



Dear Jon,

I think the terms small and large might not be same for all disease. For instance a clinical trial including 20 patients with a rare condition/disease still is large. Despite this, I suggest Phases (encompassing the terms large/small) of clinical trials as used in PubMed (Article Types) or clinicaltrials<http://www.nlm.nih.gov/services/ctphases.html>. Also, Wikipedia<http://en.wikipedia.org/wiki/Clinical_trial#Phases> has mentioned number of participants in each phase but I couldn't find its Reference.

I have the as same question as Philipp's. Is this about new upgrades of TRIP?

Bests,

Farhad





On Wed, Jun 5, 2013 at 7:40 PM, Jon Brassey <[log in to unmask]<mailto:[log in to unmask]>> wrote:

Hi All,



This is a strange question, but would welcome any advice.  I'm trying to create a system to categorise the size of trials, based on the number of participants.  I'm thinking it'd be something like very small, small, medium, large and very large.



I could arbitrarily say something like:





  *   very small trial = less than 20 patients

  *   small = 21-99

  *   medium = 100-499

  *   large = 500-4999

  *   very large = 5000+

But, is there already some work in this area?



BW



jon



--



Jon Brassey

Trip Database

http://www.tripdatabase.com

Find evidence fast









--

Farhad Shokraneh, BSc, MS, MedLIS



Iranian Center for Evidence-Based Medicine,

Tabriz University of Medical Sciences, Tabriz, Iran

Cell Phone: +98 (0) 9149567734

Google Scholar Profile<http://scholar.google.com/citations?hl=en&user=bpljzVEAAAAJ&view_op=list_works&pagesize=100>

ResearchGate Profile<https://www.researchgate.net/profile/Farhad_Shokraneh/>



------------------------------



Date:    Wed, 5 Jun 2013 21:28:13 +0000

From:    "Yao, Xiaomei" <[log in to unmask]>

Subject: Re: Categorising the size of a clinical trial



[Message contains invalid MIME fields or encoding and could not be processed]



------------------------------



End of EVIDENCE-BASED-HEALTH Digest - 4 Jun 2013 to 5 Jun 2013 (#2013-141)

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