Quality assessment of randomized controlled trials (new for Update #2)
| Author | Year | Randomization method described? | Allocation concealment method described? | Groups similar at baseline? | Comments | Inclusion criteria specified? | Exclusion criteria specified? | Outcome assessors masked? | Care provider masked? | Patients masked? | Attrition reported? | Loss to fu differential or high? | Comments | ITT analysis? | Comment | Post-randomization exclusions ? | Comment | Withdrawal rate differential or high? | Comment | Handling of carryover effects (for crossover studies only) | Funding |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Berry | 2006 | Method not described | Method not described | Yes | Yes | NR | NR | NR | Yes | No | Unable to determine | No | No | ||||||||
| Fava | 2006 | Method not described | Method not described | Yes | Yes | Yes | Unclear, reported as double blind | Unclear, reported as double blind | Unclear, reported as double blind | Yes | 50/545 (9.2%), not differential | Yes | 543/545 analyzed (99.6%) | Yes | 40 for protocol violation, did not meet entry criteria, or “other” | Yes | 172/545 (31.6%) | Sepracor | |||
| Kryger | 2007 | Method not described | Method not described | NR | Not reported by order of randomization | Yes | Yes | Unclear, reported as double blind | Unclear, reported as double blind | Yes | Yes | No | Yes | No | No | no dropouts | washout | Takeda | |||
| Krystal 2008 | 2008 | Method not described | Method not described | Yes | Yes | Yes | Unclear, reported as double blind | Unclear, reported as double blind | Yes | Yes | Yes | 77/1018 (7.6%) | Yes | 1016/1025 analyzed (99.1%) | Yes | 43 for poor compliance | Yes | 405/1018 (39.8%) | Sanofi- Aventis | ||
| McCall | 2006 | Method not described | Method not described | Yes | Yes | Yes | Yes | Unclear, reported as double blind | Unclear, reported as double blind | Yes | No | Unable to determine | No | No | 9/264 (3.4%) | Sepracor | |||||
| Rosenberg | 2007 | Method not described | Method not described | NR | Not reported by order of randomization | Yes | Yes | Unclear, reported as double blind | Unclear, reported as double blind | Unclear, reported as double blind | Yes | No | Yes | Yes | 1 excluded for protocol violation | No | 1/22 (4.5%) | washout | Sepracor | ||
| Roth 2007 | 2007 | Method not described | Method not described | Yes | Yes | Yes | Unclear, reported as double blind | Unclear, reported as double blind | Unclear, reported as double blind | Yes | No | Yes | No | No | No dropouts | washout | Takeda | ||||
| Soares | 2006 | Method not described | Method not described | Yes | Yes | Yes | Unclear, reported as double blind | Unclear, reported as double blind | Unclear, reported as double blind | Yes | No | 4/410 (1%) | Yes | Yes | 13 for protocol violation, did not meet entry criteria, or other | No | 51/410 (12.4%) | Sepracor | |||
| Walsh | 2008 | Method not described | Yes | No | Number of awakenings and sleep quality higher in placebo group (different directions) | Yes | Yes | Yes | Unclear, reported as double blind | Yes | Yes | No | Yes | 199/205 analyzed (97.1%) | Yes | 1 for poor compliance | No | 7/205 (3.4%) | Sanofi- Aventis | ||
| Walsh (eszopiclone) | 2007 | Method not described | Method not described | Yes | Yes | Yes | Yes | Yes | Yes | Yes | No | 9.6% | Yes | 548/550 analyzed | Yes | 35 discontinued for protocol violation; 20 for other reasons | Yes | More placebo patients discontinued (52% vs 37%) 80/830 discontinued overall (9.6%) | Sepracor | ||
| Zammit (ramelteon) | 2007 | Method not described | Yes | No | Differences in weight and sex at baseline | Yes | Yes | Yes | Yes | Yes | No | 1/405 | No | Yes | 6 for protocol deviation, 1 for noncompliance | No | 34/405 withdrew (8.4%); not reported by group | Takeda |
From: Evidence Tables
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