CONSORT checklists for results,discussion and interpretation.

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Dear

members, so far we have covered introduction and methods of consort 2010

statement. Now next posting is related to results, discussion and interpretation mentioned

in checklist items.All the examples as well as explanations are sourced from consort website.

Results

Participant Flow:

Here

a diagram (flow chart) is strongly recommended. We can download templates of

the CONSORT 2010 flow diagram( MS Word and in PDF.)

Item 13a - For each group, the

numbers of participants who were randomly assigned, received intended treatment, and was analyzed for the

primary outcome.

Losses and exclusions

Item

13b - For each group, losses and exclusions after randomization, together with reasons.

The nature of the protocol deviation and the exact reason for excluding

participants after randomization should always be reported.

Recruitment

Item 14a.

Dates defining the periods of recruitment and follow-up:

To know when a study took

place and over what period participants were recruited. Knowing the rate at

which participants were recruited may also be useful, especially to other

investigators

Reason for stopped trial

Item 14b - Why the trial ended

or was stopped?

Authors have to disclose why

the trial came to an end. The report should also disclose factors extrinsic to

the trial that affected the decision to stop the trial, and who made the

decision to stop the trial, including reporting the role the funding agency

played in the deliberations and in the decision to stop the trial.

Baseline

data

Item 15 - A table showing baseline demographic and

clinical characteristics for each group

Although proper random

assignment prevents selection bias, it does not guarantee that the groups are

equivalent at baseline. Any differences in baseline characteristics are,

however, the result of chance rather than bias.

The study groups should be

compared at baseline for important demographic and clinical characteristics so

that readers can assess how similar they were.

Numbers analysed

Item 16 - For each group,

number of participants (denominator) included in each analysis and whether the

analysis was by original assigned groups.

Examples

"The primary analysis was intention-to-treat and involved all patients

who were randomly assigned."

"One patient in the test group

(total 32 patients) was lost to follow up; thus data from 31 patients were

available for the intention-to-treat analysis. Five patients were considered

protocol violators … consequently 26 patients remained for the per-protocol

analysis.

This "intention-to-treat"

strategy is not always straight forward to implement. It is common for some

patients not to complete a study—they may drop out or be withdrawn from active

treatment—and thus are not assessed at the end. Excluding participants from the

analysis can lead to erroneous conclusions.

Outcomes

and estimation

Item 17a - For each primary and secondary outcome,

results for each group, and the estimated effect size and its precision (such

as 95% confidence interval).

Study results should be reported as a summary of the outcome in each group

together with the contrast between the groups, known as the effect size.

Item 17b - For binary outcomes, presentation

of both absolute and relative effect sizes is recommended.

Ancillary analyses

Item 18 - Results of any

other analyses performed, including subgroup analyses and adjusted analyses,

distinguishing pre-specified from exploratory.

Analyses that were

pre-specified in the trial protocol are much more reliable than those suggested

by the data, and therefore authors should report which analyses were

prespecified

Multiple analyses of the same

data create a risk for false positive findings.

A survey found that

unacknowledged discrepancies between protocols and publications were found for

all 25 trials reporting subgroup analysis.

Harms

Item 19 - All important harms

or unintended effects in each group.

The existence and nature of

adverse effects can have a major impact on whether a particular intervention

will be deemed acceptable and useful.

Randomized trials offer the best approach for providing safety data as

well as efficacy data, although they cannot detect rare harms.

Discussion

Limitations

Item 20 -

Trial limitations, addressing sources of potential bias and imprecision.

Although discussion of limitations is frequently omitted from research

reports, but identification and discussion of the weaknesses of a study have

particular importance. It is usually found helpful for further research

methodology.

Authors should also discuss any imprecision of the results. Imprecision

may arise in connection with several aspects of a study, including measurement

of a primary outcome or diagnosis.

Generalisability

Item 21 -

Generalisability (external validity, applicability) of the trial findings:

Here following questions should be answered.Can results be generalised to

an individual participant or groups that differ from those enrolled in the

trial with regard to age, sex, severity of disease, and comorbid conditions?

Are the results applicable to

other drugs within a class of similar drugs, to a different dose, timing, and

route of administration, and to different concomitant therapies?

Can similar results be

expected at the primary, secondary, and tertiary levels of care?

Interpretation

Item 22 - Interpretation

consistent with results, balancing benefits and harms, and considering other

relevant evidence.

Readers will want to know how

the present trial's results relate to those of other RCTs. This can best be

achieved by including a formal systematic review in the results or discussion

section of the report.

At a minimum, the discussion

should be as systematic as possible and be based on a comprehensive search,

rather than being limited to studies that support the results of the current

trial.