Table 2.
Frequency of reporting in journal abstracts of surgical randomized controlled trials according to the CONSORT extension for abstracts
| RCTs published from 2005 to 2007 | RCTs published from 2014 to 2016 | Odds ratio (95% CI) | Mean difference (95% CI) | p value | |
|---|---|---|---|---|---|
| Included studies | 192 | 164 | |||
| Reporting in journal abstract | |||||
| Title: Identification of the study as randomized | 160 (83.3%) | 154 (93.9%) | 3.08 (1.41–7.25) | – | 0.0021 |
| Trial design: description of the trial design | 130 (67.7%) | 133 (81.1%) | 2.04 (1.21–3.48) | – | 0.0042 |
| Participants: eligibility criteria for the participants and the setting where the data were collected | 21 (10.9%) | 34 (20.7%) | 2.12 (1.14–4.05) | – | 0.0108 |
| Interventions intended for each group | 163 (84.9%) | 151 (92.1%) | 2.07 (1.00–4.49) | – | 0.0364 |
| Specific objective or hypothesis | 148 (77.1%) | 153 (93.3%) | 4.14 (2.00–9.20) | – | <0.0001 |
| Clearly defined primary outcome | 54 (28.1%) | 101 (61.6%) | 4.10 (2.56–6.56) | – | <0.0001 |
| Randomization: how participants were allocated to interventions | 1 (0.5%) | 4 (2.4%) | 4.82 (0.47–238.3) | – | 0.1229 |
| Blinding: whether or not participants, caregivers, and those assessing the outcomes were blinded to group assignment | 19 (9.9%) | 22 (13.4%) | 1.41 (0.70–2.87) | – | 0.2999 |
| aBlinding: term like “single-blind”, “double-blind”, “blinded” without further definition also accepted | 44 (22.9%) | 55 (33.5%) | 1.70 (1.04–2.79) | – | 0.0258 |
| Number of participants randomized to each group | 100 (52.1%) | 97 (59.2%) | 1.33 (0.86–2.07) | – | 0.1815 |
| Number of participants analyzed in each group | 38 (19.8%) | 51 (31.1%) | 1.83 (1.09–3.06) | – | 0.0141 |
| Outcome: for the primary outcome, a result for each group and the estimated effect size and its precision | 43 (22.4%) | 85 (51.8%) | 3.73 (2.30–6.05) | – | <0.0001 |
| Harms: important adverse events or side effects | 110 (57.3%) | 107 (65.2%) | 1.40 (0.89–2.20) | – | 0.1253 |
| Conclusion: general interpretation of the results | 188 (97.9%) | 162 (98.8%) | 1.72 (0.24–19.25) | – | 0.5280 |
| Trial registration: registration number and name of trial register | 4 (2.1%) | 76 (46.3%) | 40.59 (14.39–156.08) | – | <0.0001 |
| Funding: source of funding | 0 (0%) | 0 (0%) | Not estimable | – | – |
| Average score (95% CI) | 6.14 (5.90–6.38%) | 8.11 (7.83–8.39%) | – | 1.97 (1.60–2.33) | <0.0001 |
| aSensitivity analysis: average score (95% CI) | 6.27 (6.02–6.52%) | 8.31 (8.03–8.59%) | – | 2.04 (1.67–2.41) | <0.0001 |
Average score of adequatley reported CONSORT-A items (main finding) are given in bold
CI confidence interval
aIn the sensitivity analyses general terms like “single-blind”, “double-blind”, “blinded” were considered as adequate reporting