Unclear Insomnia Concept in Randomized Controlled Trials and Systematic Reviews: A Meta-Epidemiological Study
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design
2.2. Types of Studies Included
2.3. Search Methods
2.4. Study Selection and Data Extraction
2.5. Statistical Analysis
2.6. Differences between the Protocol and the Article
2.7. Ethics
3. Results
3.1. Selection Process
3.2. Proportions and Trends of RCT and SR Abstracts in Which Insomnia Concept Was Unclear
3.3. The Percentage of Unclear Insomnia Concept of RCT and SR Abstracts If We Consider What Was Stated in the Full Text
3.4. Characteristics of RCT and SR Abstracts with Unclear Insomnia Concept, and the Relationship between the Characteristics and Unclear Definitions in Abstracts
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Category | Subcategory | RCT n = 88 | SR n = 94 |
---|---|---|---|
Intended insomnia concept | Unclear insomnia concept | 24 (27) | 54 (57) |
Insomnia disorder | 5 (6) | 12 (13) | |
Insomnia symptoms | 43 (49) | 23 (24) | |
Both insomnia disorder and insomnia symptoms | 16 (18) | 5 (5) |
Category | Subcategory | RCTs | SRs | ||
---|---|---|---|---|---|
Unclear Insomnia Concept n = 88 | Clear Insomnia Concept n = 12 | Unclear Insomnia Concept n = 94 | Clear Insomnia Concept n = 6 | ||
Impact Factor | 0 to 4 | 58 (66) | 10 (83) | 46 (49) | 4 (67) |
5 to 9 | 17 (19) | 1 (8) | 35 (37) | 1 (17) | |
10 or more | 8 (9) | 1 (8) | 4 (4) | 1 (17) | |
No value | 5 (6) | 0 (0) | 9 (10) | 0 (0) | |
Word counts in abstracts | median 270 (IQR 244 to 311) | median 288 (IQR 272 to 298) | median 279 (IQR 237 to 387) | median 246 (IQR 241 to 257) | |
Word limitations in abstracts | Less than 300 | 64 (73) | 9 (75) | 39 (41) | 4 (67) |
300 or more | 20 (23) | 2 (17) | 43 (46) | 1 (17) | |
Unclear | 4 (5) | 1 (8) | 12 (13) | 1 (17) | |
Funding | None | 12 (14) | 1 (8) | 53 (56) | 3 (50) |
Industry | 29 (33) | 5 (42) | 3 (3) | 0 (0) | |
Non-industry | 47 (53) | 6 (50) | 38 (40) | 3 (50) | |
Compliance with reporting guidelines | No compliance | 77 (88) | 12 (100) | 46 (49) | 3 (50) |
Compliance | 11 (13) | 0 (0) | 48 (51) | 3 (50) | |
Registrations or protocols | No registrations/protocols | 21 (24) | 4 (33) | 63 (67) | 6 (100) |
Registrations/protocols | 67 (76) | 8 (67) | 31 (33) | 0 (0) | |
Journal names that included sleep | Non-sleep journal | 68 (77) | 9 (75) | 90 (96) | 5 (83) |
Sleep journal | 20 (23) | 3 (25) | 4 (4) | 1 (17) |
Category | Subcategory | RCTs (n = 100) | SRs (n = 100) | ||
---|---|---|---|---|---|
Crude OR (95% CI) | AOR (95% CI) | Crude OR (95% CI) | AOR (95% CI) | ||
Impact factor | 0 to 4 | Ref | Ref | Ref | Ref |
5 to 9 | 2.09 (0.35, 12.57) | 1.97 (0.33, 11.81) | 2.29 (0.34, 15.29) | 1.69 (0.23, 12.55) | |
10 or more | 1.02 (0.16, 6.51) | 1.43 (0.14, 14.26) | 0.29 (0.04, 2.34) | 0.50 (0.05, 4.99) | |
No value | 1.97 (0.10, 38.43) | 4.09 (0.11, 149.78) | 1.84 (0.09, 37.08) | 4.22 (0.15, 121.40) | |
Word counts in abstracts | 1.00 (0.99, 1.01) | 1.00 (0.99, 1.01) | 1.00 (0.99, 1.01) | 1.00 (1.00, 1.01) | |
Word limitations in abstracts | Less than 300 | Ref | Ref | Ref | Ref |
300 or more | 1.21 (0.28, 5.30) | 1.44 (0.28, 7.42) | 3.30 (0.50, 22.03) | 2.18 (0.28, 16.92) | |
Unclear | 0.44 (0.06, 3.17) | 0.31 (0.03, 3.44) | 0.95 (0.13, 6.70) | 0.63 (0.07, 5.44) | |
Funding | None | Ref | Ref | Ref | Ref |
Industry | 0.64 (0.09, 4.40) | 0.71 (0.10, 5.33) | 0.46 (0.02, 10.73) | 0.77 (0.03, 22.63) | |
Non-industry | 0.88 (0.13, 5.76) | 0.79 (0.11, 5.90) | 0.72 (0.15, 3.35) | 0.79 (0.17, 3.64) | |
Compliance with reporting guidelines | No compliance | Ref | Ref | Ref | Ref |
Compliance | 3.71 (0.21, 67.00) | 3.05 (0.16, 57.19) | 1.04 (0.22, 4.84) | 0.87 (0.19, 4.02) | |
Registrations or protocols | No registrations/protocols | Ref | Ref | Ref | Ref |
Registrations/protocols | 1.66 (0.48, 5.75) | 1.60 (0.40, 6.35) | 6.45 (0.35, 118.14) | 6.40 (0.36, 114.28) | |
Journal names that included sleep | Non-sleep journal | Ref | Ref | Ref | Ref |
Sleep journal | 0.81 (0.22, 3.04) | 0.77 (0.18, 3.30) | 0.18 (0.02, 1.40) | 0.38 (0.03, 4.42) |
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Banno, M.; Tsujimoto, Y.; Kohmura, K.; Dohi, E.; Taito, S.; Someko, H.; Kataoka, Y. Unclear Insomnia Concept in Randomized Controlled Trials and Systematic Reviews: A Meta-Epidemiological Study. Int. J. Environ. Res. Public Health 2022, 19, 12261. https://doi.org/10.3390/ijerph191912261
Banno M, Tsujimoto Y, Kohmura K, Dohi E, Taito S, Someko H, Kataoka Y. Unclear Insomnia Concept in Randomized Controlled Trials and Systematic Reviews: A Meta-Epidemiological Study. International Journal of Environmental Research and Public Health. 2022; 19(19):12261. https://doi.org/10.3390/ijerph191912261
Chicago/Turabian StyleBanno, Masahiro, Yasushi Tsujimoto, Kunihiro Kohmura, Eisuke Dohi, Shunsuke Taito, Hidehiro Someko, and Yuki Kataoka. 2022. "Unclear Insomnia Concept in Randomized Controlled Trials and Systematic Reviews: A Meta-Epidemiological Study" International Journal of Environmental Research and Public Health 19, no. 19: 12261. https://doi.org/10.3390/ijerph191912261