Introduction

2. Background This section describes the rationale: why you did the trial when you did it, why you designed it as you did, summarizing briefly the state of knowledge at the time the trial was designed. It is appropriate to indicate here any changes to the trial design or hypotheses during its conduct, and the reasons for them. It is important to be clear

Table 10.1 CONSORT checklist for reporting a randomized trial

Heading

Item number

Descriptor

Title and abstract

1

Identify the study as a randomized trial

Introduction

Scientific background and rationale

Background

2

Methods

Participants

3

Eligibility criteria for participants and the settings and locations where the data were collected

Interventions

4

Precise details of the interventions intended for each group and how and when they were actually administered

Objectives

5

Specify objectives and hypotheses

Outcomes

6

Clearly defined primary and secondary outcome measure(s) and, when applicable, any methods used to enhance the quality of measurements (e.g. multiple observations, training of assessors)

Sample size

7

How sample size was determined and, when applicable, explanation of any interim analyses and stopping rules

Randomization

Sequence generation

8

Method used to generate the allocation sequence, including details of any restriction (e.g. blocking, stratification)

Allocation concealment

9

Method used to implement the random allocation sequence (e.g. numbered containers, central telephone) clarifying whether the sequence was concealed until interventions were assigned.

Implementation

10

Who generated the allocation sequence, who enrolled participants, and who assigned participants to their groups?

Blinding (masking)

11

Whether or not participants, those administering the interventions and those assessing the outcomes were aware of group assignment. If not, how the success of masking was assessed.

Statistical methods

12

Statistical methods used to compare groups for primary outcomes(s); methods for additional analyses, such as subgroup analyses and adjusted analyses.

Results

Participant flow

13

Flow of participants through each stage (a diagram is strongly recommended). Specifically for each group report the numbers of participants randomly assigned, receiving intended treatment, completing the study protocol, and analysed for the primary outcome. Describe protocol deviations from study as planned together with reasons.

Recruitment

14

Dates defining the periods of recruitment and follow-up.

Baseline data

15

Baseline demographic and clinical characteristics of each group

Numbers analysed

16

Number of participants (denominator) in each group included in each analysis and whether the analysis was by 'intention to treat.' State results in absolute numbers when feasible (e.g. 10/20 not 50 per cent).

Outcomes and estimation

17

For each primary and secondary outcome, a summary of results for each group, and the estimated effect size and its precision (e.g. 95 per cent CI)

Ancillary analyses

18

Address multiplicity by reporting any other analyses performed, including subgroup analyses and adjusted analyses indicating those prespecified and those exploratory.

Adverse events

19

All important adverse events or side effects in each intervention group

Discussion

Interpretation

20

Interpretation of the results, taking into account study hypotheses, sources of potential bias or imprecision and the dangers associated with multiplicity of analyses and outcomes

Generalizability

21

Generalizability (external validity) of the trial findings

Overall evidence

22

General interpretation of the results in the context of current evidence

O cc

Assessed for eligibility (n = ...)

Excluded (n = ...) Not meeting inclusion criteria (n = ...) Refused to participate (n = .) Other reasons (n = .)

w

Randomized (n = .)

Lost to follow-up: give reasons (n = ...) Discontinued intervention: give reasons (n = ...)

Analysed (n = ...) Excluded from analysis: give reasons (n = ..)

Allocated to intervention (n = ...) Received allocated intervention (n = ...) Did not receive allocated intervention: give reasons (n = ...)

Allocated to intervention (n =...) Received allocated intervention (n = .) Did not receive allocated intervention: give reasons (n = ...)

Lost to follow-up: give reasons (n = ...) Discontinued intervention: give reasons (n = ...)

Analysed (n = ...) Excluded from analysis: give reasons (n = ..)

Fig. 10.1 General flow diagram of a randomized trial.

and honest about which additional analyses were pre-planned, which were suggested by events or information emerging independently of the trial and which were data-driven, since the confidence which can be attached to the results of the analyses decline in this order.

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