PAPER SECTION
And topic

Description

1

The title is ‘Randomised trial....’

The abstract includes Design: Randomised trial with 8 groups

2

The rationale is explained in Introduction

3

Eligibility criteria for participants are described in methods. Patients excluded and recruited, and the setting where the data were collected, are described below (in 14).

Interventions

4

Details are given in methods and in web extra 3.

Objectives

5

Details given at the end of Introduction.

Outcomes

6

Details given in methods.

Sample size

7

Sample size calculations are shown below. There were no interim analyses or stopping rules.

Randomization --
Sequence generation

8

See below

Randomization --
Allocation concealment

9

See below

Randomization --
Implementation

10

See below

Blinding (masking)

11

Participants could not be blinded for this type of intervention. Outcomes were assessed by self completed questionnaire.

Statistical methods

12

This is described in methods with additional detail being given below.

13. RESULTS

Participant flow

13

See Figure 1. Flow of participants by three intervention factors is shown below.

Recruitment

14

Details given below

Baseline data

15

Baseline demographic and clinical characteristics of each group are given in the text and in Table 1. There were no significant differences between intervention factors.

Numbers analyzed

16

Number of participants in each group included in each analysis is shown in Figure 1. Analysis was by "intention-to-treat" although the main analysis presented does not include those lost to follow-up as we think this presents a clearer picture. ‘Full’ intention to treat analysis is presented below.

Outcomes and estimation

17

There are no major differences apart from the percentage showing the booklet to their confidant; a 95% confidence interval is given for that percentage.

Ancillary analyses

18

Most analyses were pre-specified.

Adverse events

19

The slightly greater drop out rate for those allocated to anxiety management advice groups is described below.

DISCUSSION
Interpretation

20

Although all statistically significant results are reported they have only been taken as robust when supported by other outcomes.

Generalizability

21

See discussion.

Overall evidence

22

See discussion.