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Table 1 Reporting of items on the CONSORT Extension for Pilot and Feasibility Trials

From: Reporting quality of pilot clinical trials in chronic kidney disease patients on hemodialysis: a methodological survey

CONSORT Items

n

%

Lower 95% CI

Upper 95% CI

N

Title and Abstract

 

 1a. Identification as a pilot or feasibility randomized trial in the title

52

60.5%

49.9%

70.3%

86

 1b. Structured summary of pilot trial design, methods, results, and conclusions (for specific guidance see CONSORT abstract extension for pilot trials)

79

91.9%

84.7%

96.3%

86

Introduction

 2a. Scientific background and explanation of rationale for future definitive trial, and reasons for randomized pilot trial

23

26.7%

18.3%

36.8%

86

 2b. Specific objectives or research questions for pilot trial

84

97.7%

92.7%

99.5%

86

Methods

 Trial design

  3a. Description of pilot trial design (such as parallel, factorial) including allocation ratio

36

41.9%

31.8%

52.4%

86

  3b. Important changes to methods after pilot trial commencement (such as eligibility criteria), with reasons

5

5.8%

2.3%

12.3%

86

 Participants

  4a. Eligibility criteria for participants

80

93.0%

86.2%

97.0%

86

  4b. Settings and locations where the data were collected

57

66.3%

55.9%

75.6%

86

  4c. How participants were identified and consented

58

67.4%

57.1%

76.6%

86

 Interventions

  5. The interventions for each group with sufficient details to allow replication, including how and when they were actually administered

74

86.0%

77.6%

92.1%

86

 Outcome measurement

  6a. Completely defined prespecified assessments or measurements to address each pilot trial objective specified in 2b, including how and when they were assessed

79

91.9%

84.7%

96.3%

86

  6b. Any changes to pilot trial assessments or measurements after the pilot trial commenced, with reasons

3

3.5%

1.0%

9.0%

86

  6c. If applicable, prespecified criteria used to judge whether, or how, to proceed with future definitive trial*

7

9.0%

4.1%

16.8%

78

 Sample size

  7a. Rationale for numbers in the pilot trial

24

27.9%

19.3%

38.0%

86

  7b. When applicable, explanation of any interim analyses and stopping guidelines*

3

7.9%

2.3%

19.6%

38

 Randomization

  8a. Method used to generate the random allocation sequence

30

34.9%

25.4%

45.3%

86

  8b. Type of randomization(s); details of any restriction (such as blocking and block size)

24

27.90%

19.3%

38.0%

86

 Allocation concealment mechanism

  9. 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

22

25.60%

17.3%

35.5%

86

 Implementation

  10. Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions

16

18.60%

11.5%

27.8%

86

 Blinding

  11a. If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how*

33

43.40%

32.7%

54.6%

76

  11b. If relevant, description of the similarity of interventions*

20

71.40%

53.2%

85.5%

28

 Statistical methods

  12. Methods used to address each pilot trial objective whether qualitative or quantitative

84

97.70%

92.7%

99.5%

86

Results

  Participant flow

  13a. For each group, the numbers of participants who were approached and/or assessed for eligibility, randomly assigned, received intended treatment, and were assessed for each objective

62

72.10%

62.0%

80.7%

86

  13b. For each group, losses and exclusions after randomization, together with reasons

66

76.70%

67.0%

84.7%

86

 Recruitment

  14a. Dates defining the periods of recruitment and follow-up

37

43.00%

32.9%

53.6%

86

  14b. Why the pilot trial ended or was stopped

8

9.30%

4.5%

16.8%

86

 Baseline data

  15. A table showing baseline demographic and clinical characteristics for each group

72

83.70%

74.9%

90.4%

86

 Numbers analyzed

  16. For each objective, number of participants (denominator) included in each analysis. If relevant, these numbers should be by randomized group

39

45.30%

35.1%

55.9%

86

 Outcomes and estimation

  17. For each objective, results including expressions of uncertainty (such as 95% confidence interval) for any estimates. If relevant, these results should be by randomized group

70

81.40%

72.2%

88.5%

86

 Ancillary analyses

  18. Results of any other analyses performed that could be used to inform the future definitive trial*

13

21.30%

12.5%

32.8%

61

 Harms

  19. All important harms or unintended effects in each group (for specific guidance see CONSORT for harms)

48

55.80%

45.3%

66.0%

86

  19a. If relevant, other important unintended consequences*

19

27.90%

18.4%

39.4%

68

Discussion

 Limitations

  20. Pilot trial limitations, addressing sources of potential bias and remaining uncertainty about feasibility

63

73.30%

63.2%

81.7%

86

 Generalisability

  21. Generalisability (applicability) of pilot trial methods and findings to future definitive trial and other studies

38

44.20%

34.0%

54.7%

86

 Interpretation

  22. Interpretation consistent with pilot trial objectives and findings, balancing potential benefits and harms, and considering other relevant evidence

84

97.70%

92.7%

99.5%

86

  22a. Implications for progression from pilot to future definitive trial, including any proposed amendments

14

16.30%

9.6%

25.1%

86

 Other information: Registration

  23. Registration number for pilot trial and name of trial registry

27

31.40%

22.3%

41.7%

86

 Protocol

  24. Where the pilot trial protocol can be accessed, if available

7

8.10%

3.7%

15.3%

86

 Funding

  25. Sources of funding and other support (such as supply of drugs), role of funders

61

70.90%

60.8%

79.7%

86

  26. Ethical approval or approval by research review committee, confirmed with reference number

53

61.60%

51.1%

71.4%

86

  1. Note: Italics indicates bottom 10%, and bold indicates top 10%
  2. *Studies for which the item was not applicable were not included in the total N
  3. N = total number of studies (i.e., numerator); n = count