e- discussion on consort 2010 statement

[Guest guest]

Dear members,Today I would

conclude my discussion with final checklists of consort on registration, accessibility of

protocol on the web and funding information. We will also discuss the

limitation of consort statement and reporting of randomized trials other than

two parallel

Groups.

Other

information

Registration

Item

23 - Registration number and name of trial registry.

According to World Health

Organization "the registration of all interventional trials is a scientific,

ethical and moral responsibility" (www.who.int/ictrp/en).

By registering a randomized

trial, authors typically report a minimal set of information and obtain a

unique trial registration number.eg. One can register his trial at

ClinicalTrials.gov and will get number like NCT00244842.

Protocol

Item

24 - Where the full trial protocol can be accessed, if available?

A protocol for the complete

trial is important because it pre-specifies the methods of the randomized

trial, such as the primary as well as secondary outcome. As described in the

example below, journals reporting a trial's primary results can make the trial

protocol available on their web site and their trial protocol can be easily

accessible to interested readers.eg. "Full details of the trial protocol can be

found in the Supplementary Appendix, available with the full text of this

article at www.nejm.org."

Item 25 - Sources of funding

and other support (such as supply of drugs), role of funders.

Studies have showed that research

sponsored by the pharmaceutical industry

are more likely to produce results favouring the product made by the company

sponsoring the research than studies funded by other sources. So it is of

immense importance that author should report about the funding source.

-------------------…………………----------------------

What

about reporting RCTs that did not have a two group parallel design?

1.

For multiarm trial with more than two groups----

parallel group trials need the least modification of the standard CONSORT

guidance.

The main differences from

trials with two groups relate to clarification of how the study hypotheses

relate to the multiple groups, and the consequent methods of data analysis and

interpretation.

2. For factorial trials, the

possibility of interaction between the interventions generally needs to be

considered.

3. In crossover trials, each

participant receives two (or more) treatments in a random order. The main

additional issues relate to the paired nature of the data, which affect design

and analysis.

The CONSORT Group intends to publish extensions to CONSORT to cover all

these designs. When if in doubt, authors, editors, and readers

should consult the CONSORT website for any CONSORT extensions, expansions,

implementations, or other guidance that may be relevant.

What are limitations of consort ?

·

Might encourage reporting fictitiously the information suggested by

guidance rather than actual.

·

Does not recommend for designing and conducting RTs:

how

& what author did……

how & what author should have done

???

·

Not a tool to evaluate quality of

trial

Conclusion

The CONSORT statement can really

help researchers designing trials in future and can guide peer reviewers and

editors in their evaluation of manuscripts. Peer reviewers and editors should

use the CONSORT checklist to assess whether authors have reported on these

items and this assessment will definitely improve the clarity and transparency

of published trials.

Because CONSORT is an evolving

document, it requires a dynamic process of continual assessment, refinement,

and, if necessary, changes, that is why CONSORT group regularly update the

checklist and explanatory article.

There is no doubt that the quality of trial reporting has improved since

publication of the CONSORT statement in 2001, but still it remains well below

an acceptable level. The researchers conclude that more journals should endorse

CONSORT and, most importantly, they should do more to ensure adherence as

awareness and endorsement are still lagging behind.

As most of indexed journals have adopted CONSORT guidelines---- Authors

should understand these guidelines before starting a trial to design and then

conduct trials according to rigorous standards.—there is no doubt why it would

not be helpful in publication.