1. STROBE Statement revision
Updating a reporting guideline: Experiences from the revision of CONSORT
Doug Altman
STROBE Statement revision

2. CONSORT 1996 Not the first reporting guideline
Arguably the first high impact consensus guideline
Involvement of editors

5. Rationale for checklist items
Necessary to evaluate the study
Evidence-based, whenever possible
Minimum set of essential items

6. 2001 Revision of CONSORT
Major revision begun in 2000 – published in 2001
Checklist – major revision
Flow diagram – small changes
“The CONSORT Statement”
Short paper published in 3 journals

9. “Explanation and elaboration” paper
Major innovation: Explanatory paper (E&E)
To enhance the use and dissemination of CONSORT
For each checklist item: examples of good reporting and explanation, with relevant empirical evidence
14000 words

10. Update of 2001 CONSORT Meeting in January 2007
Preparatory discussions identified issues of major importance for detailed discussion
Did not discuss every checklist item
Agenda
Possible new items
Funding, registration
Possibly modified items
Outcomes, Baseline information
Attrition
Selective outcome reporting
Reporting stopping
Blinding
Discussion sections
Composite outcomes
Flow diagrams
Surrogate outcomes

11. Update of 2001 CONSORT Meeting in January 2007
We agreed in principle what to add, modify, remove
Only rarely discussed specific checklist wording
Influenced by empirical evidence
We identified issues to develop in updated E&E paper
e.g. missing data
Wordsmithing of revised checklist was done later by the CONSORT executive
Examined all text whether or not changes had been discussed
Many iterations
Sent to wider group for approval
STROBE Statement revision

12. “CONSORT 2010” Short paper (published in 9 journals)
Revised (and expanded) explanatory paper (E&E) (2 journals)

13. Major changes in 2010 Added 3 completely new items
Registration, Protocol, Funding
Added new item to clarify trial design
Added several sub-items
e.g. changes to the primary and secondary outcome (endpoint) measures after the trial commenced
Removed one sub-item
Testing blinding
Made some items more specific
e.g. allocation concealment mechanism, blinding
Changes are documented in the paper

14. Some cosmetic and other adjustments
We simplified and clarified the wording across several checklist items
We improved consistency of style across the items
We enhanced ease of implementation by breaking some items into sub-items
We completely revised the CONSORT explanation and elaboration document
Unfortunately no shorter!
312 references

15. STROBE Statement revision
24 August 2010
STROBE Statement revision

16. Only 6 items remained unchanged
24 August 2010
STROBE Statement revision

17. Evolution of the CONSORT Statement
Outcomes
CONSORT 1996
“Primary and secondary outcome measure(s) …”
CONSORT 2001
“Clearly defined primary and secondary outcome measures …”
CONSORT 2010
“Completely defined prespecified primary and secondary outcome measures, including how and when they were assessed”

18. Evolution of the CONSORT Statement
Interventions
CONSORT 1996
“Planned interventions and their timing”
CONSORT 2001
“Precise details of the interventions intended for each group and how and when they were actually administered”
CONSORT 2010
“The interventions for each group with sufficient details to allow replication, including how and when they were actually administered”

19. CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel-Group Randomized Trials
25 item checklist
4 stage flow diagram (unchanged from 2001)
Schulz KF, et al. AIM, BMJ, JCE, Lancet, Obstetrics & Gynecology, PLoS Medicine, Open Medicine, and Trials, In Press

20. STROBE Statement revision
STROBE Statement revision

21. STROBE Statement revision
QUOROM  PRISMA
STROBE Statement revision

22. STROBE Statement revision
PRISMA 2009
STROBE Statement revision