| Literature DB >> 31315871 |
Fang Hua1,2, Qiao Sun3, Tingting Zhao3, Xiong Chen4, Hong He3.
Abstract
OBJECTIVES: To evaluate the reporting quality of randomised controlled trial (RCT) abstracts presented at a leading international conference in sleep medicine (the SLEEP Annual Meeting), and to investigate the association between potential predictors and the reporting quality of trial abstracts in this field.Entities:
Keywords: congresses as topic; data reporting; randomized controlled trial as topic; sleep medicine specialty
Year: 2019 PMID: 31315871 PMCID: PMC6661648 DOI: 10.1136/bmjopen-2019-029270
Source DB: PubMed Journal: BMJ Open ISSN: 2044-6055 Impact factor: 2.692
Characteristics of included abstracts
| Characteristic | Category | N (%) |
| Year | 2016 | 53 (30.1) |
| 2017 | 64 (36.4) | |
| 2018 | 59 (33.5) | |
| No of authors | <4 | 21 (11.9) |
| 4–7 | 88 (50.0) | |
| >7 | 67 (38.1) | |
| Continent | North America | 135 (76.7) |
| Europe | 15 (8.5) | |
| Oceania | 15 (8.5) | |
| Asia | 8 (4.6) | |
| South America | 3 (1.7) | |
| Type of intervention | Pharmacological | 44 (25.0) |
| Non-pharmacological | 132 (75.0) | |
| No of centres | Single centre | 160 (90.9) |
| Multicentre | 16 (9.1) | |
| Word count | <250 | 3 (1.7) |
| 251–300 | 17 (9.7) | |
| 301–350 | 125 (71.0) | |
| >350 | 31 (17.6) | |
| Research area | Insomnia | 96 (54.5) |
| Sleep-related breathing disorders | 48 (27.3) | |
| Others | 32 (18.2) | |
| Sample size | <25 | 46 (26.1) |
| 25–100 | 63 (35.8) | |
| >100 | 67 (38.1) | |
| Funded by industry | Yes | 46 (26.1) |
| No | 130 (73.9) | |
| Overall | 176 (100) |
Reporting of each CONSORT checklist item and subitem in the included 176 abstracts
| Items | Criteria and subitems | N (%) |
| 1. Title | Identification of the study as randomised | 52 (29.5) |
| 2. Authors | Contact details for the corresponding author | 0 (0) |
| 3. Trial design | Description of the trial design (eg, parallel, crossover) | 57 (32.4) |
| 4. Participant | Eligibility criteria for participants and the settings where the data were collected | 16 (9.1) |
| 4a. Eligibility criteria for participants | 170 (96.6) | |
| 4b. Settings of data collection | 16 (9.1) | |
| 5. Interventions | Interventions intended for each group | 130 (73.9) |
| 6. Objective | Specific objective or hypothesis | 170 (96.6) |
| 7. Outcome | Clearly defined primary outcome for this report | 28 (15.9) |
| 8. Randomisation | How participants were allocated to interventions | 0 (0) |
| 8a. Random assignment | 176 (100) | |
| 8b. Sequence generation | 0 (0) | |
| 8 c. Allocation concealment | 0 (0) | |
| 9. Blinding (masking) | Whether or not participants, caregivers and those assessing the outcomes were blinded | 14 (8.0) |
| 9a. Generic description only (eg, single blind, double blind) | 45 (25.6) | |
| 10. Numbers randomised | No of participants randomised to each group | 79 (44.9) |
| 11. Recruitment | Trial status (eg, ongoing, closed to recruitment, closed to follow-up) | 41 (23.3) |
| 12. Numbers analysed | No of participants analysed in each group | 24 (13.6) |
| 12a. Intention-to-treat analysis or per-protocol analysis | 12 (6.8) | |
| 13. Outcome | For the primary outcome, a result for each group and the estimated effect size and its precision | 0 (0) |
| 13a. Primary outcome result for each group | 11 (6.3) | |
| 13b. Estimated effect size | 5 (2.8) | |
| 13 c. Precision of the estimate (eg, 95% CI) | 3 (1.7) | |
| 14. Harms | Important adverse events or side effects | 22 (12.5) |
| 15. Conclusions | General interpretation of the results | 172 (97.7) |
| 15a. Benefits and harms balanced | 10 (5.7) | |
| 16. Trial registration | Registration no and name of trial register | 6 (3.4) |
| 17. Funding | Source of funding | 162 (92.0) |
*Outcome reported in Methods section.
†Outcome reported in Results section.
CONSORT, Consolidated Standards of Reporting Trials.
Linear regression-derived coefficients (B) and 95% CIs, with overall quality score as the dependent variable for included abstracts
| Predictor | Category/unit | Univariable | Multivariable | ||||||
| B | 95% CI | P value | B | 95% CI | Tolerance | VIF | P value | ||
| Year | 1 year | 0.07 | (−0.22 to 0.36) | 0.632 | |||||
| No of authors | 1 person | 0.10 | (0.02 to 0.18) |
| 0.05 | (−0.03 to 0.13) | 0.87 | 1.15 | 0.216 |
| Continent | North America | Reference | |||||||
| Europe | 0.74 | (−0.08 to1.56) | 0.078 | ||||||
| Oceania | 0.54 | (−0.28 to 1.36) | 0.197 | ||||||
| Asia | 0.73 | (−0.37 to 1.83) | 0.191 | ||||||
| South America | −0.39 | (−2.16 to 1.37) | 0.661 | ||||||
| Type of Intervention | Pharmacological | Reference | Reference | ||||||
| Non-pharmacological | −1.02 | (−1.53 to -0.51) |
| −0.70 | (−1.27 to to -0.12) | 0.73 | 1.37 |
| |
| No of centres | Single centre | Reference | |||||||
| Multicentre | 0.45 | (−0.35 to 1.25) | 0.267 | ||||||
| Word count | 1 word | 0.00 | (−0.01 to 0.01) | 0.923 | |||||
| Research area | Insomnia | Reference | Reference | ||||||
| Sleep-related breathing disorders | 0.78 | (0.25 to 1.31) |
| 0.42 | (−0.13 to 0.97) | 0.77 | 1.30 | 0.135 | |
| Others | 0.42 | (−0.19 to 1.03) | 0.179 | −0.17 | (−0.80 to 0.47) | 0.77 | 1.30 | 0.599 | |
| Sample size | 1 participant | −0.001 | (−0.00 to 0.00) | 0.139 | |||||
| Funded by industry | Yes | Reference | Reference | ||||||
| No | −1.08 | (−1.58 to -0.58) |
| −0.66 | (−1.24 to -0.08) | 0.72 | 1.40 |
| |
For multivariable analysis, constant=6.106, R2=0.153, adjusted R2=0.128, p<0.001.
VIF, variance inflation factor.
Bold values are those indicating statistical significance.
Reporting quality of each CONSORT checklist item and subitem by type of intervention
| Items | Criteria and subitems | Pharmacological | Non-pharmacological | Risk ratio |
| 1. Title | Identification of the study as randomised | 20 (45.5) | 32 (24.2) |
|
| 2. Authors | Contact details for the corresponding author | 0 (0) | 0 (0) | NE |
| 3. Trial design | Description of the trial design (eg, parallel, cross-over) | 19 (43.2) | 38 (28.8) | 0.66 (0.43 to 1.03) |
| 4. Participant | Eligibility criteria for participants and the settings where the data were collected | 2 (4.5) | 14 (10.6) | 2.33 (0.55 to 9.87) |
| 4a. Eligibility criteria for participants | 40 (90.9) | 130 (98.5) | 1.08 (0.98 to 1.19) | |
| 4b. Settings of data collection | 2 (4.5) | 14 (10.6) | 2.33 (0.55 to 9.87) | |
| 5. Interventions | Interventions intended for each group | 39 (88.6) | 91 (68.9) |
|
| 6. Objective | Specific objective or hypothesis | 44 (100) | 126 (95.5) |
|
| 7. Outcome | Clearly defined primary outcome for this report | 12 (27.3) | 16 (12.1) |
|
| 8. Randomisation | How participants were allocated to interventions | 0 (0) | 0 (0) | NE |
| 8a. Random assignment | 44 (100) | 132 (100) | 1.00 (1.00 to 1.00) | |
| 8b. Sequence generation | 0 (0) | 0 (0) | NE | |
| 8 c. Allocation concealment | 0 (0) | 0 (0) | NE | |
| 9. Blinding (masking) | Whether or not participants, caregivers, and those assessing the outcomes were blinded | 5 (11.4) | 9 (6.8) | 0.60 (0.21 to 1.70) |
| 9a. Generic description only (eg, single blind, double blind) | 27 (61.4) | 18 (13.6) |
| |
| 10. Numbers randomised | No of participants randomised to each group | 17 (38.6) | 62 (47.0) | 1.22 (0.80 to 1.84) |
| 11. Recruitment | Trial status (eg, ongoing, closed to recruitment, closed to follow-up) | 12 (27.3) | 29 (22.0) | 0.81 (0.45 to 1.44) |
| 12. Numbers analysed | No of participants analysed in each group | 8 (18.2) | 16 (12.1) | 0.67 (0.31 to 1.45) |
| 12a. Intention-to-treat analysis or per-protocol analysis | 2 (4.5) | 10 (7.6) | 1.67 (0.38 to 7.32) | |
| 13. Outcome | For the primary outcome, a result for each group and the estimated effect size and its precision | 0 (0) | 0 (0) | NE |
| 13a. Primary outcome result for each group | 4 (9.1) | 7 (5.3) | 0.58 (0.18 to 1.90) | |
| 13b. Estimated effect size | 1 (2.3) | 4 (3.0) | 1.33 (0.15 to 11.61) | |
| 13c. Precision of the estimate (eg, 95% CI) | 1 (2.3) | 2 (1.5) | 0.67 (0.06 to 7.17) | |
| 14. Harms | Important adverse events or side effects | 17 (38.6) | 5 (3.8) |
|
| 15. Conclusions | General interpretation of the results | 40 (90.9) | 132 (100) | 1.10 (1.00 to 1.21) |
| 15a. Benefits and harms balanced | 8 (18.2) | 2 (1.5) |
| |
| 16. Trial registration | Registration no and name of trial register | 2 (4.5) | 4 (3.0) | 0.67 (0.13 to 3.52) |
| 17. Funding | Source of funding | 40 (90.9) | 122 (92.4) | 1.02 (0.91 to 1.13) |
*Outcome reported in Methods section.
†Outcome reported in Results section.
CONSORT, Consolidated Standards of Reporting Trials; NE, not estimable due to zero cell counts.
Bold values are those indicating statistical significance.
Reporting quality of each CONSORT checklist item and subitem by funding status
| Items | Criteria and subitems | Funded by industry (n=46), | Not funded by industry/unreported | Risk ratio |
| 1. Title | Identification of the study as randomised | 24 (52.2) | 28 (21.5) |
|
| 2. Authors | Contact details for the corresponding author | 0 (0) | 0 (0) | NE |
| 3. Trial design | Description of the trial design (eg, parallel, crossover) | 22 (47.8) | 35 (26.9) |
|
| 4. Participant | Eligibility criteria for participants and the settings where the data were collected | 3 (6.5) | 13 (10.0) | 1.53 (0.46 to 5.14) |
| 4a. Eligibility criteria for participants | 43 (93.5) | 127 (97.7) | 1.05 (0.96 to 1.13) | |
| 4b. Settings of data collection | 3 (6.5) | 13 (10.0) | 1.53 (0.46 to 5.14) | |
| 5. Interventions | Interventions intended for each group | 38 (82.6) | 92 (70.8) | 0.86 (0.72 to 1.02) |
| 6. Objective | Specific objective or hypothesis | 45 (97.8) | 125 (96.2) | 0.98 (0.93 to 1.04) |
| 7. Outcome | Clearly defined primary outcome for this report | 12 (26.1) | 16 (12.3) |
|
| 8. Randomisation | How participants were allocated to interventions | 0 (0) | 0 (0) | NE |
| 8a. Random assignment | 46 (100) | 130 (100) | NE | |
| 8b. Sequence generation | 0 (0) | 0 (0) | NE | |
| 8 c. Allocation concealment | 0 (0) | 0 (0) | NE | |
| 9. Blinding (masking) | Whether or not participants, caregivers, and those assessing the outcomes were blinded | 8 (17.4) | 6 (4.6) |
|
| 9a. Generic description only (eg, single blind, double blind) | 25 (54.3) | 20 (15.4) |
| |
| 10. Numbers randomised | No of participants randomised to each group | 16 (34.8) | 63 (48.5) | 1.39 (0.90 to 2.15) |
| 11. Recruitment | Trial status (eg, ongoing, closed to recruitment, closed to follow-up) | 11 (23.9) | 30 (23.1) | 0.97 (0.53 to 1.77) |
| 12. Numbers analysed | No of participants analysed in each group | 6 (13.0) | 18 (13.8) | 1.06 (0.45 to 2.51) |
| 12a. Intention-to-treat analysis or per-protocol analysis | 2 (4.3) | 10 (7.7) | 1.77 (0.40 to 7.78) | |
| 13. Outcome | For the primary outcome, a result for each group and the estimated effect size and its precision | 0 (0) | 0 (0) | NE |
| 13a. Primary outcome result for each group | 4 (8.7) | 7 (5.4) | 0.62 (0.19 to 2.02) | |
| 13b. Estimated effect size | 1 (2.2) | 4 (3.1) | 1.42 (0.16 to 12.34) | |
| 13c. Precision of the estimate (eg, 95% CI) | 1 (2.2) | 2 (1.5) | 0.71 (0.07 to 7.62) | |
| 14. Harms | Important adverse events or side effects | 15 (32.6) | 7 (5.4) |
|
| 15. Conclusions | General interpretation of the results | 43 (93.5) | 129 (99.2) | 1.06 (0.98 to 1.15) |
| 15a. Benefits and harms balanced | 8 (17.4) | 2 (1.5) |
| |
| 16. Trial registration | Registration no and name of trial register | 2 (4.3) | 4 (3.1) | 0.71 (0.13 to 3.74) |
| 17. Funding | Source of funding | 46 (100) | 116 (89.2) |
|
*Outcome reported in Methods section.
†Outcome reported in Results section.
CONSORT, Consolidated Standards of Reporting Trials; NE, Not estimable due to zero cell counts.
Bold values are those indicating statistical significance.