Table 3 Percentage of adequately reported individual CONSORT and CONSORT extension items

Item

Section

CONSORT item

Reported

WebCONSORT

(n = 94)

Control (n = 103)

1

Outcomes (6a)

Completely defined pre-specified primary outcome measure, including how and when they were assessed

Yes

68 (72%)

79 (77%)

2

Sample size (7a)

How sample size determined

Yes

77 (82%)

85 (83%)

3

Sequence generation (8a)

Method used to generate random allocation sequence

Yes

69 (73%)

78 (76%)

4

Allocation concealment (9)

Mechanism used to implement random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned

Yes

60 (64%)

57 (55%)

5

Blinding (11a)*

If done, who was blinded after assignment to interventions (for example, participants care providers those assessing outcomes)

Yes

44 (47%)

36 (35%)

6

Outcomes and estimation (17a)

For the primary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence intervals)

Yes

41 (44%)

45 (44%)

7

Harms (19)

All-important harms or unintended effects in each group

Yes

63 (67%)

73 (71%)

8

Registration (23)

Registration number and name of trial registry

Yes

75 (80%)

71 (69%)

9

Protocol (24)

Where trial protocol can be assessed, if available

Yes

21 (22%)

20 (19%)

10

Funding (25)

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

Yes

32 (34%)

35 (34%)

Flow diagram

Reported

WebCONSORT (n = 94)

Control

(n = 103)

(flow diagram reported in revised manuscript)

Yes

80 (85%)

89 (86%)

Participant flow (13a)

For each group, the numbers of participants randomly assigned,

Yes

87 (93%)

99 (96%)

received intended treatment, and were analysed for the primary outcome

Yes

68 (72%)

82 (80%)

Yes

81 (86%)

88 (85%)

(13b)

For each group, losses and exclusions after randomisation, together with reason

Yes

83 (88%)

87 (84%)

Section

Extension item

Reported

WebCONSORT

(n = 10)

Control

(n = 9)

1

Background and objectives (2a)

Rationale for using cluster design

Yes

3 (30%)

3 (33%)

2

Sample size (7a)

Method of calculation, number of cluster(s) (and whether equal or unequal cluster sizes are assumed), a coefficient of intra-cluster correlation (ICC or k), and an indication of its uncertainty

Yes

2 (20%)

1 (11%)

3

Randomisation (10b)

Mechanism by which individual participants were included in clusters for the purposes of the trial (such as complete enumeration, random sampling)

Yes

3 (30%)

0 (0%)

4

Statistical methods (12a)

How clustering was taken into account

Yes

4 (40%)

3 (33%)

5

Outcomes and estimation (17a)

Results at individual or cluster level as applicable and a coefficient correlation of ICC or k for each primary outcome

Yes

0 (0%)

1 (11%)

Section

Extension item

Reported

WebCONSORT

(n = 9)

Control

(n = 8)

1

Background and objectives (2a & b)

Rationale for using a non-inferiority design

Hypothesis concerning non inferiority, specifying the non-inferiority margin with the rationale for its choice

Yes

2 (22%)

1 (12%)

2

Interventions (5)

Whether the reference treatment in the non-inferiority trial is identical (or very similar) to that in any trial(s) that established efficacy

Yes

4 (44%)

0 (0%)

3

Sample size (7a)

Whether the sample size was calculated using non inferiority criterion and, if so, what the non-inferiority margin was

Yes

5 (55%)

3 (37.5%)

4

Statistical methods (12a)

Whether a one- or two-sided confidence interval approach was used

Yes

5 (56%)

4 (50%)

5

Outcomes and estimation (17a)

For the outcome(s) for which non-inferiority was hypothesized, a figure showing confidence intervals and the non-inferiority margin may be useful

Yes

2 (22%)

1 (12%)

Section

Extension item

Reported

WebCONSORT

(n = 20)

Control

(n = 16)

1

Participants (3)

Eligibility criteria should be explicitly framed to show the degree to which they include typical participants and/or where applicable, typical providers (e.g. nurses), institutions (e.g. hospitals), communities (or localities, e.g. towns) and settings of care (e.g. different healthcare financing systems)

Yes

NA

7 (35%)

1 (5%)

2 (12.5%)

3 (19%)

2

Interventions (4)

Describe extra resources added to (or resources removed from) usual settings in order to implement intervention; indicate if efforts were made to standardise the intervention or if the intervention and its delivery were allowed to vary between participants, practitioners, or study sites; describe the comparator in similar detail to the intervention

Yes

7 (35%)

4 (25%)

3

Outcomes (6)

Explain why the chosen outcomes are considered important to those who will use the results of the trial and, when relevant, why the length of follow-up is considered important to those who will use the results of the trial

Yes

2 (10%)

3 (19%)

4

Sample size (7)

If calculated using the smallest difference considered important by the target decision maker audience (the minimally clinically important difference) then report where this difference was obtained

Yes

4 (20%)

3 (19%)

5

Blinding (11)

If blinding was not done, or was not possible, explain why

Yes

4 (20%)

2 (12.5%)

Section

Extension item

Reported

WebCONSORT (n = 43)

Control

(n = 50)

1

Participants (3)

When applicable, eligibility criteria for centres and those performing the interventions

Yes

NA

6 (14%)

18 (42%)

4 (8%)

22 (44%)

2

Interventions (4a, b, c)

a) Description of the different components of the interventions and, when applicable, description of the procedure for tailoring the interventions to individual participants

b) Details of how the interventions were standardised

c) Details of how adherence of care providers with the protocol was assessed or enhanced

Yes

4 (9%)

2 (4%)

3

Sequence generation (8)

When applicable, how care providers were allocated to each trial group

Yes

NA

6 (14%)

20 (47%)

3 (6%)

30 (60%)

4

Statistical methods (12)

When applicable, details of whether and how clustering by care providers or centres was addressed

Yes

NA

4 (9%)

35 (81%)

5 (10%)

36 (72%)

5

Baseline data (15)

When applicable, a description of care providers (case volume, qualification, expertise, etc.) in each group and centres (volume) in each group

Yes

NA

4 (9%)

9 (21%)

5 (10%)

18 (36%)

Section

Extension item

Reported

WebCONSORT

(n = 2)

Control

(n = 0)

1

Intervention: Details of needling (2b)

Names (or location if no standard name) of points used (uni/bilateral)

Yes

2 (100%)

0

2

(2c)

Depth of insertion, based on a specified unit of measurement, or on a particular tissue level

Yes

2 (100%)

0

3

(2d)

Response sought (e.g. de qi or muscle twitch response)

Yes

1 (50%)

0

4

(2e)

Needle stimulation (e.g. manual, electrical)

Yes

2 (100%)

0

5

(2f)

Needle retention time

Yes

1 (50%)

0

Section

Extension item

Reported

WebCONSORT

(n = 2)

Control

(n = 13)

1

Intervention: Herbal medicinal product name (4a)

The Latin binomial name together with botanical authority and family name for each herbal ingredient; common name(s) should also be included; the proprietary product name (i.e. brand name) or the extract name (e.g. EGb-761) and the name of the manufacturer of the product; whether the product used is authorised (licensed, registered) in the country in which the study was conducted.

Yes

1 (50%)

5 (38%)

2

Characteristics of the herbal product (4b)

The part(s) of plant used to produce the product or extract. The type of product used (e.g. raw [fresh or dry], extract); the type and concentration of extraction solvent used (e.g. 80% ethanol, 100% H₂O, 90% glycerin, etc.) and the ratio of herbal drug to extract (e.g. 2 to 1); the method of authentication of raw material (i.e. how done and by whom) and the lot number of the raw material

Yes

0

0

3

Dosage regimen and quantitative description (4c)

The dosage of the product, the duration of administration and how these were determined; the content (e.g. as weight, concentration; may be given as range where appropriate) of all quantified herbal product constituents, both native and added, per dosage unit form; added materials, such as binders, fillers, and other excipients (e.g. 17% maltodextrin, 3% silicon dioxide per capsule), should also be listed

Yes

0

2 (15%)

4

Qualitative testing (4d)

Product’s chemical fingerprint and methods used (equipment and chemical reference standards) and who performed the chemical analysis (e.g. the name of the laboratory used); whether a sample of the product (i.e. retention sample) was retained and if so, where it is

Kept or deposited; description of any special testing/purity testing (e.g. heavy metal or other contaminant testing) undertaken, which unwanted components were removed and how (i.e. methods)

Standardization: what to standardise (e.g. which chemical components of the product) and how (e.g. chemical processes or biological/functional measures of activity)

Yes

0

0

5

Practitioner (4f)

Description of practitioners (e.g. training and practice experience) part of the intervention

Yes

0

0