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Table 2 Publication adherence to CONSORT checklist for abstract of pilot trials n = 92

From: Quality of pilot trial abstracts in heart failure is suboptimal: a systematic survey

 

Item

Criteria

Count

Percent (95% CI)

Title

Identifier

Title identifies the study is a randomized controlled pilot trial

65

71 (60; 79)

Description

Trial design

Description of pilot trial design (e.g., parallel or cluster)

30

33 (23; 44)

Method

Eligibility

Eligibility criteria for each participant

81

88 (78; 94)

Settings

Setting where pilot was conducted

29

32 (22; 47)

Interventions

Interventions intended for each group

91

99 (91; 99)

Objectives

Specific objectives of the pilot trial

89

94 (89; 99)

Outcomes

Pre-specified assessment or measurement to address the pilot trial objectives

89

97 (90; 98)

Randomization sequence generation

Describe how participants were allocated to the interventions

12

13 (8; 19)

Blinding (masking)

Whether or not participants, caregivers, and those assessing the outcomes were blinded to group assignment

20

22 (15; 31)

Results

Number randomized

Number of participants screened

15

16 (9; 26)

Number randomized to each group for the pilot objectives

41

45 (36; 53)

 

Recruitment

Trial status (for conference abstracts)

2

2 (5; 8)

 

Numbers analyzed

Number of participants analyzed in each group of pilot objectives

15

16 (11; 24)

 

Harm

Important adverse events or side effects

28

30 (23; 39)

Conclusion

Result interpretation

General interpretation of results of pilot trial

80

87(76; 93)

Plans

Any implication for future trial

20

22 (15; 30)

Registration

Trial registration

Registration number of trial

12

13 (7; 21)

 

Funding

Source of funding

1

1 (0.16; 6.9)

  1. CI confidence interval