Table 2.
GRADE Assessment of Randomized Clinical Trials
| Certainty Assessment |
Summary of Findings |
|||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No. of Patients |
Effect |
Certainty | Importance | |||||||||
| Outcome Examined (No. of Studies) | Study Design | Risk of Bias | Inconsistency | Indirectness | Imprecision | Other Considerations | Procalcitonin Arm | Control Arm | Estimate (95% CI) | Absolute (95% CI) | ||
| Critical Illness | ||||||||||||
| Mortality (16) | Randomized trials | Seriousa | Not serious | Seriousb | Not serious | None | 496/2,500 (19.8%) | 552/2,500 (22.1%) | RR, 0.89 (0.83-0.97) | 24 fewer per 1,000 (from 10 to 40 fewer) | ⊕⊕◯◯ (low) | Critical |
| Hospital length of stay (11) | Randomized trials | Seriousc | Seriousd | Not serious | Not serious | None | MD, –0.59 d (–3.70 to 2.51) | … | ⊕⊕◯◯ (low) | Important | ||
| ICU length of stay (15) | Randomized trials | Seriouse | Seriousd | Not serious | Not serious | None | MD, –0.48 d (–2.90 to 1.95) | … | ⊕⊕◯◯ (low) | Important | ||
| Antibiotic duration or exposure (13) | Randomized trials | Seriousf | Seriousd | Not serious | Not serious | None | MD, –1.31 d (–2.27 to –0.35) | … | ⊕⊕◯◯ (low) | Important | ||
| Sepsis and Critical Illness | ||||||||||||
| Mortality (10) | Randomized trials | Seriousg | Not serious | Seriousb | Not serious | None | 243/1,096 (22.2%) | 250/1,064 (23.5%) | RR, 0.94 (0.85-1.03) | Not estimable | ⊕⊕◯◯ (low) | Critical |
| Hospital length of stay (7) | Randomized trials | Serioush | Seriousd | Not serious | Not serious | None | MD, –0.27 d (–5.00 to 4.46) | … | ⊕⊕◯◯ (low) | Important | ||
| ICU length of stay (10) | Randomized trials | Seriousg | Seriousd | Not serious | Not serious | None | MD, –0.69 d (–4.72 to 3.34) | … | ⊕⊕◯◯ (low) | Important | ||
| Antibiotic duration or exposure (9) | Randomized trials | Seriousi | Seriousd | Not serious | Not serious | None | MD, –0.96 d (–1.82 to –0.10) | … | ⊕⊕◯◯ (low) | Important | ||
GRADE = Grading of Recommendations, Assessment, Development and Evaluation; MD = mean difference; RR = risk ratio.
All studies unblinded to participants and personnel; incomplete outcome data (7/15 studies); no data on random sequence generation (4/15 studies); no data on allocation concealment (8/15 studies).
A sensitivity analysis showed that studies with higher adherence (> 80%) to procalcitonin-guided algorithm showed no significant benefit whereas studies with lower adherence (< 80%) showed benefit.
All studies unblinded to participants and personnel; incomplete outcome data (7/10 studies), no data on random sequence generation (1/10 studies); no data on allocation concealment (5/10 studies).
I2 values exceed 75%.
All studies unblinded to participants and personnel; incomplete outcome data (7/14 studies); no data on random sequence generation (5/14 studies); no data on allocation concealment (9/14 studies).
All studies unblinded to participants and personnel; incomplete outcome data (5/12 studies); no data on random sequence generation (4/12 studies); no data on allocation concealment (7/12 studies).
All studies unblinded to participants and personnel; incomplete outcome data (5/10 studies); no data on random sequence generation (3/10 studies); no data on allocation concealment (7/10 studies).
All studies unblinded to participants and personnel; incomplete outcome data (5/7 studies); no data on allocation concealment (4/7 studies).
All studies unblinded to participants and personnel; incomplete outcome data (4/9 studies); no data on random sequence generation (2/9 studies); no data on allocation concealment (6/9 studies).