This document summarizes a lecture about transparency and openness in research. It discusses the CONSORT statement, which was developed to standardize the reporting of randomized controlled trials. CONSORT began in the 1990s and has been revised over time, with the 2010 statement providing a checklist of essential items to include in trial reports. The lecture also notes that CONSORT has been expanded to provide guidelines for specifically reporting different types of trials and that hundreds of other reporting guidelines have been developed for other research areas as well.

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Transparent Repor(ng

2. Transparency &
Openness Promo(on
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3. Transparency &
Openness Promo(on
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4. Transparency &
Openness Promo(on
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5. The CONSORT
Statement
• Consolidated Standards of Repor)ng Trials (CONSORT)
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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.

6. 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
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1993
1996
1999
2007

7. 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
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8. CONSORT:
The 2010 Checklist
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9. CONSORT Extensions
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10. CONSORT PLUS
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hkp://rctbank.ucsf.edu/home/cplus/full-list

11. 100s of Other
Repor(ng Guidelines
• The EQUATOR Network lists hundreds of repor)ng guidelines
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hkp://www.equator-network.org

12. Cochrane Systema(c
Review on Repor(ng
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13. Repor(ng Results of
Registered Trials
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