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Table 2 CONSORT checklist items for assessment from abstracts of included RCTs

From: Assessment of adherence to the CONSORT statement for quality of reports on randomized controlled trial abstracts from four high-impact general medical journals

Items Assessment criteria Assessment of individual journals, n(%) Overall, n(%) (n = 271)
   NEJM (n = 113) Lancet (n = 80) JAMA (n = 43) BMJ (n = 35)  
Title Study identified as randomized in title 5 (4.4) 79 (98.6) 41 (95.3) 34 (97.1) 159 (58.7)
  Mentioned random/randomized in abstract 110 (97.3) 80 (100) 43 (100) 35 (100) 268 (98.9)
Authors Addresses including postal and emails 75 (66.4) 54 (67.5) 33 (76.7) 29 (82.9) 191 (70.5)
  Only postal address 24 (21.2) 26 (32.5) 7 (16.3) 6 (17.1) 64 (23.6)
Trial design Descriptions provided (parallel, factorial, crossover, etc.) 21 (18.6) 23 (28.8) 9 (20.9) 10 (28.6) 63 (23.3)
Methods       
Participants Eligibility criteria with settings of data collection 29 (25.7) 61 (76.3) 40 (93.0) 35 (100) 165 (60.9)
  Only eligibility criteria provided 111 (98.2) 80 (100) 43 (100) 35 (100) 269 (99.3)
Interventions Details including denomination, usage, course of treatment for both groups 97 (85.8) 74 (92.5) 40 (93.0) 35 (100) 246 (90.8)
Objective Specific objective/hypothesis 40 (35.4) 80 (100) 42 (97.7) 35 (100) 197 (72.7)
  Only background described 73 (64.6) - 1 (0.9) - 74 (27.3)
Outcome Clearly defined primary outcome 99 (87.6) 80 (100) 43 (100) 35 (100) 257 (94.8)
Randomization Reported the method of random sequence generation 8 (7.1) 71 (88.6) 3 (7.0) 2 (5.7) 84 (31.0)
  Allocation concealment - 31 (38.6) - 1 (2.9) 32 (11.8)
Blinding Generic description* 40 (35.4) 26 (32.5) 20 (46.5) 16 (45.7) 102 (37.6)
  Detailed description++ 2 (1.8) 46 (57.5) 6 (14.0) 3 (8.6) 57 (21.0)
Results       
Numbers randomized Number of participants randomized in each group 58 (51.3) 79 (98.6) 32 (74.4) 22 (62.9) 191 (70.5)
Numbers analyzed Number of participants analyzed for each group 58 (51.3) 77 (96.3) 30 (69.8) 21 (60.0) 186 (68.7)
Outcomes Primary outcome result for each group 87 (76.9) 78 (97.5) 39 (90.7) 24 (68.6) 228 (84.1)
  For primary outcome, effect size and confidence interval reported (in total) 35 (31.0) 54 (67.5) 24 (55.8) 15 (42.9) 128 (47.2)
  Effect size and confidence interval (trials with binary outcome) 26 (out of 50) (52.0) 33 (out of 45) (73.3) 12 (out of 19) (63.2) 10 (out of 15) (66.7) 81 (out of 127) (63.8)
  Effect size and confidence interval (trials with continuous outcome) 0 (out of 8) 8 (out of 13)(61.5) 5 (out of 10)(50.0) 2 (out of 6)(33.3) 15 (out of 37) (40.5)
Harms Adverse event or side effect reported 53 (46.9) 50 (62.5) 7 (16.3) 6 (17.1) 116 (42.8)
Conclusions Discussed benefit or harm from the intervention 28 (24.8) 13 (16.3) 5 (11.6) 9 (25.7) 55 (20.3)
  Stated only the benefit from the intervention 84 (74.3) 65 (81.3) 38 (88.4) 25 (71.4) 212 (78.2)
Trial registration Reported registration number and name of trial register 113 (100) 78 (97.5) 43 (100) 35 (100) 269 (99.3)
Funding Reported the source of funding 52 (46.0) 77 (96.3) - - 129 (47.6)
  1. *S imply stating single-blind or double-blind; ++ blinding explained between patients and caregivers, investigators, or outcome assessors.