Table 1

The most important items of the Consolidated Standards of Reporting Trials (CONSORT) 2010 statement and bullet points that early career peer reviewers will assess

OutcomesItem 6a. Completely defined prespecified primary outcome measures, including how and when they were assessed i 
Was the primary outcome(s) clearly identify (eg, the primary/main outcome was pain)?
If no go to next section
If yes answer the following questions,
Please check if the author clearly report for the primary outcome(s):
  • The variable of interest (eg, pain, all-cause mortality)

  • How the outcome was assessed (eg, VAS, Beck Depression Inventory score, pain scale)

  • The analysis metric (eg, change from baseline, final value, time to event)

  • The summary measure for each study group (eg, mean, proportion with score>2)

  • Time point of interest for analysis (eg, 3 months) * NA if survival analysis

  • Who assessed the outcome (eg, the patient, doctor, nurse, caregiver, other)

Sequence generation
Item 8a. Method used to generate the random allocation sequence
Did the author report:
  • The method of sequence generation (eg, a random number table or computerised random number generator, or other)

Allocation concealmentItem 9. Mechanism used to implement the random allocation sequence (eg, sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned
Did the author report:
  • How the care provider enrolling patients was blinded to the next assignment in the sequence. Possible methods can rely on

  • For centralised or ‘third-party’ assignment (ie, use of a central telephone randomisation system, automated assignment system)

  • Having a third party prepare the randomisation list and hide the allocation assignment in advance via numbered identical bottles or sequentially numbered, sealed, opaque envelopes

  • If the mechanism of the random allocation sequence is completely described but the sequence is not adequately concealed, please tick yes

BlindingWas the study blinded yes/ no
  • If yes go to 11a

  • If no go to 13a

Item 11a. If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how
Item 11b. If relevant, description of the similarity of interventions
Did the author report:
  • Who (ie, participants, healthcare providers, data collectors, outcome adjudicators, and data analysts) was blinded to treatment assignments?

  • How was performed the blinding? (eg, used of placebo, intervention by physician unaware of the study)

  • The similarities of the characteristics of the interventions (eg, appearance, taste, smell, method of administration)*NA

Participant flowItem 13a. For each group, the numbers of participants who were randomly assigned, received intended treatment and were analysed for the primary outcome
Item 13b. For each group, losses and exclusions after randomisation, together with reasons
Did the authors report a flow chartYesNo
Did the author report in the flow chart or in the text:
  • Number of participants randomised in each group

  • Number of participants who received intended treatment in each group

  • Number of participants did not receive the allocated treatment with reasons in each group

  • Number of participants lost to follow-up with reasons in each group

  • Number of participants who discontinued intervention with reasons in each group

  • Number of participants analysed for the primary outcome in each group

  • Number excluded from analysis with reasons in each group

Outcomes and estimationItem 17a. For each primary outcome, results for each group, and the estimated effect size and its precision (such as 95% CI)
Did the author report for primary outcome: (answer yes if it is true for all primary outcomes)
  • Result in each group (mean (SD) or nb of event/n)

  • Difference in estimated effect between groups (eg, OR, risk ratio (RR), risk difference (RD), HR, difference in median survival time, mean difference (MD))

  • Precision for difference between groups (eg, 95% CI)

HarmsItem 19. All important harms or unintended effects in each group
Did the author report:
  • How harms-related information was collected (eg, mode of data collection, timing, attribution methods)

  • For each group, participant withdrawals due to harm

  • Results in each group for each harms type with denominator (mean (SD) or nb of event/n)

RegistrationItem 23. Registration number and name of registry
Did the author report:
  • The registration number

Consistency between data registered and reported
Did authors report the same primary outcome in the register and manuscript (same variable, same metric, same time point) or was the primary outcome added, deleted, changed
If the study was not registered, please tick the box
If the study was registered, report
 □ The link to the online registry:
 □ Date of the registration:
 □ Date of the start of the study:
Was the primary outcome(s) reported in the register or manuscript not sufficiently described to identify switch in outcomes?YesNo
Did you identified any outcome(s) reported by the authors as primary outcome(s) while not registered as such?YesNo
Did you identified any outcome(s) registered as primary outcome but not reported as such in the manuscript?YesNoi
Did you identified any change in terms of time frame, metric or other information between the primary outcome(s) registered and reported in the manuscript?YesNo
If yes, please list the discrepancies:
Did the authors justify the switched outcome(s) in the manuscript?YesNoNA