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2016-10-17		|		UC	Berkeley	 Alasdair	Cohen		|		Lecture	for	Publich	Health	250B	 46	
Transparent Repor(ng
Transparency &
Openness Promo(on
2016-10-17		|		UC	Berkeley	
Alasdair	Cohen		|		Lecture	for	Publich	Health	250B	
47
Transparency &
Openness Promo(on
2016-10-17		|		UC	Berkeley	
Alasdair	Cohen		|		Lecture	for	Publich	Health	250B	
48
Transparency &
Openness Promo(on
2016-10-17		|		UC	Berkeley	
Alasdair	Cohen		|		Lecture	for	Publich	Health	250B	
49
The CONSORT
Statement
•  Consolidated	Standards	of	Repor)ng	Trials	(CONSORT)	
2016-10-17		|		UC	Berkeley	
Alasdair	Cohen		|		Lecture	for	Publich	Health	250B	
50	
MOHER,	D.,	HOPEWELL,	
S.,	SCHULZ,	K.	F.,	
MONTORI,	V.,	
GØTZSCHE,	P.	C.,	
DEVEREAUX,	P.	J.,	
ELBOURNE,	D.,	EGGER,	
M.	&	ALTMAN,	D.	G.	
2010.	CONSORT	2010	
Explana)on	and	
Elabora)on:	Updated	
guidelines	for	repor)ng	
parallel	group	
randomised	trials.	BMJ,	
340.
CONSORT:
A brief history
•  30	experts	(epidemiologist,	editors,	etc.)	meet	to	discuss	
standardized	assessment	for	trials	
•  But	they	were	limited	by	a	lack	of	reported	data	
•  So	they	created	the	Standardized	Repor)ng	of	Trials	(SORT)	statement	
•  ~Same	)me:	“Asilomar	Working	Group	on	Recommenda)ons	for	
Repor)ng	of	Clinical	Trials	in	the	Biomedical	Literature”	statement	
•  JAMA	editor	facilitates	mee)ng:	Two	groups	merge	proposals	
•  Result:	Consolidated	Standards	of	Repor)ng	Trials	(CONSORT)	
•  Follow-up	mee)ngs	yield	the	Revised	CONSORT	statement	(2001)	
•  Further	revisions,	resul)ng	in	the	CONSORT	2010	statement	
2016-10-17		|		UC	Berkeley	
Alasdair	Cohen		|		Lecture	for	Publich	Health	250B	
51	
1993	
1996	
1999	
2007
CONSORT:
Primary Resources
• “Checklist	of	informa)on	to	include	when	repor)ng	a	randomised	trial”	
• “Explana)on	and	Elabora)on	for	important	clarifica)ons	on	all	the	items”	
• CONSORT	extensions	for:	
• Cluster	randomised	trials	
• Non-inferiority	and	equivalence	trials	
• Pragma)c	trials	
• N-of-1	trials	
• Trials	using	pa)ent-reported	outcomes	(CONSORT-PRO)	
• Herbal	Medicinal	interven)ons	
• Non-pharmacological	treatment	interven)ons	
• Acupuncture	interven)ons	
2016-10-17		|		UC	Berkeley	
Alasdair	Cohen		|		Lecture	for	Publich	Health	250B	
52
CONSORT:
The 2010 Checklist
2016-10-17		|		UC	Berkeley	
Alasdair	Cohen		|		Lecture	for	Publich	Health	250B	
53
CONSORT Extensions
2016-10-17		|		UC	Berkeley	
Alasdair	Cohen		|		Lecture	for	Publich	Health	250B	
54
CONSORT PLUS
2016-10-17		|		UC	Berkeley	
Alasdair	Cohen		|		Lecture	for	Publich	Health	250B	
55	
hkp://rctbank.ucsf.edu/home/cplus/full-list
100s of Other
Repor(ng Guidelines
•  The	EQUATOR	Network	lists	hundreds	of	repor)ng	guidelines	
2016-10-17		|		UC	Berkeley	
Alasdair	Cohen		|		Lecture	for	Publich	Health	250B	
56	
hkp://www.equator-network.org
Cochrane Systema(c
Review on Repor(ng
2016-10-17		|		UC	Berkeley	
Alasdair	Cohen		|		Lecture	for	Publich	Health	250B	
57
Repor(ng Results of
Registered Trials
2016-10-17		|		UC	Berkeley	
Alasdair	Cohen		|		Lecture	for	Publich	Health	250B	
58

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