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

From: Impact of a web-based tool (WebCONSORT) to improve the reporting of randomised trials: results of a randomised controlled trial

CONSORT STATEMENT (10 most important and poorly reported CONSORT items assessed) (n = 197 manuscripts)
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%)
(For combined overall score – analysis blinding not applicable refers to where manuscript states not blinded, so scored as yes = 1)
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%)
CONSORT DESIGN EXTENSIONS (five most important and poorly reported CONSORT items assessed per extension)
Cluster trials extension selected (n=19 manuscripts)
  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%)
Non-inferiority trials extension selected (n = 17 manuscripts)
  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%)
Pragmatic trials extension selected (n = 36 manuscripts)
  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%)
CONSORT INTERVENTION EXTENSIONS (top five items per extension)
Non-pharmacologic extension selected (n = 93 manuscripts)
  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%)
Acupuncture extension selected (n = 2 manuscripts)
  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
Herbal extension selected (n = 15 manuscripts)
  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