Journal Analysis "Pico & Consort Checklist Methode": Luluk Silvia
Journal Analysis "Pico & Consort Checklist Methode": Luluk Silvia
What is Known
• Specific objectives or hypotheses
• Methode
- Description of trial design (such as parallel, factorial)
including allocation ratio
• Important changes to methods after trial
commencement (such as eligibility criteria), with
reasons
• Eligibility criteria for participants, Settings and
locations where the data were collected
• The interventions for each group with sufficient details
to allow replication, including how and when they were
actually administered
• Sample Size
- How sample size was determined
• When applicable, explanation of any interim analyses
and stopping guidelines
• Method used to generate the random allocation
sequence
• Type of randomisation; details of any restriction (such
as blocking and block size), Mechanism used to
implement the random allocation sequence (such as
sequentially numbered containers), describing any
steps taken to conceal the sequence until interventions
were assigned
• Who generated the random allocation sequence, who
enrolled participants, and who assigned participants to
interventions
• If done, who was blinded after assignment to
interventions (for example, participants, care
providers, those assessing outcomes) and how
• Statistical methods used to compare groups for
primary and secondary outcomes
• Methods for additional analyses, such as subgroup
analyses and adjusted analyses
• For each group, the numbers of participants who were
randomly assigned, received intended treatment, and
were analysed for the primary outcome
• Dates defining the periods of recruitment and follow-
up
• For each group, number of participants (denominator)
included in each analysis and whether the analysis was
by original assigned groups, For each primary and
secondary outcome, results for each group, and the
estimated effect size and its precision (such as 95%
confidence interval)
• Results of any other analyses performed, including
subgroup analyses and adjusted analyses,
distinguishing pre-specified from exploratory
• All important harms or unintended effects in each
group (for specific guidance see CONSORT for harms)
• Trial limitations, addressing sources of potential bias,
imprecision, and, if relevant, multiplicity of analyses
• Interpretation consistent with results, balancing
benefits and harms, and considering other relevant
evidence
• Registration number and name of trial registry
• Sources of funding and other support (such as supply
of drugs), role of funders