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. Author manuscript; available in PMC: 2022 Apr 1.
Published in final edited form as: J Biomed Inform. 2021 Feb 26;116:103717. doi: 10.1016/j.jbi.2021.103717

Table 2.

Descriptive statistics regarding the annotation of CONSORT checklist items in CONSORT-TM. SD: standard deviation.

CONSORT Item No. of articles Avg. number of sentences per article (±SD) Range
Title Randomized (1a) 40 0.80 (±0.40) 0–1
Structured Abstract (1b) 49 0.98 (±0.14) 0–1
Background (2a) 50 2.04 (±0.20) 2–3
Objectives (2b) 50 1.44 (±0.61) 1–3
Trial Design (3a) 49 1.48 (±0.95) 0–5
Changes to Trial Design (3b) 4 0.20 (±0.70) 0–3
Eligibility Criteria (4a) 49 3.20 (±1.56) 0–8
Data Collection Setting (4b) 40 0.96 (±0.60) 0–2
Interventions (5) 50 5.40 (±3.17) 1–15
Outcomes (6a) 50 13.22 (±7.24) 3–38
Changes to Outcomes (6b) 5 0.12 (±0.39) 0–2
Sample Size Determination (7a) 46 2.26 (±1.65) 0–8
Interim Analyses/ Stopping Guidelines (7b) 11 0.42 (±1.01) 0–5
Sequence Generation (8a) 38 0.86 (±0.61) 0–3
Randomization Type (8b) 39 1.00 (±0.70) 0–3
Allocation Concealment (9) 19 0.44 (±0.64) 0–3
Randomization Implementation (10) 30 1.14 (±1.51) 0–8
Blinding (11a) 40 1.18 (±1.38) 0–9
Similarity of Interventions (11b) 15 0.36 (±0.60) 0–2
Statistical Methods for Outcomes (12a) 50 5.44 (±2.60) 1–13
Statistical Methods for Other Analyses (12b) 29 1.44 (±1.67) 0–6
Participant Flow (13a) 45 2.52 (±1.39) 0–6
Participant Loss/Exclusion (13b) 43 2.32 (±1.65) 0–7
Periods of Recruitment/ Follow-Up (14a) 42 1.04 (±0.67) 0–3
Trial Stopping (14b) 6 0.18 (±0.63) 0–4
Baseline Data (15) 50 3.80 (±2.24) 1–12
Numbers Analyzed (16) 47 2.06 (±1.43) 0–7
Outcome Results (17a) 50 14.38 (±8.89) 2–48
Binary Outcome Results (17b) 32 3.94 (±5.59) 0–26
Ancillary Analyses (18) 37 4.50 (±4.46) 0–16
Harms (19) 45 3.88 (±3.90) 0–17
Limitations (20) 44 4.16 (±2.97) 0–11
Generalizability (21) 29 0.88 (±0.98) 0–4
Interpretation (22) 50 13.00 (±6.74) 3–40
Registration (23) 45 1.20 (±0.61) 0–2
Protocol Access (24) 7 0.16 (±0.42) 0–2
Funding (25) 50 2.52 (±1.82) 1–10