Summary of findings 2. Physical and cognitive therapy compared to standard care for preventing intensive care unit delirium.
| Physical and cognitive therapy compared to standard care for preventing intensive care unit delirium | ||||||
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Patient or population: critically ill patients 18 years or older treated for respiratory failure or septic or both, cardiogenic or haemorrhagic shock who resided within 120 miles of the city of hospital. Setting: Nashville, Tennesee, USA Intervention: One daily physical therapy session (passive ROM, active exercise, sit at edge of bed, stand/transfer, ADL training and walk). Duration of physical therapy session is not described combined with one daily physical therapy session and 20 minutes. cognitive therapy sessions twice‐daily during hospitalization. Patients exhibiting impaired executive functioning or impaired functional mobility continued outpatient cognitive therapy for six weeks (6 sessions) using goal management training. Comparison: usual care (approximately physical therapy once every six days) | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with standard care | Risk with physical and cognitive therapy | |||||
| The event rate of ICU delirium measured by the CAM‐ICU | not estimable | ‐ | ‐ | Outcome not measured by included study | ||
| In‐hospital mortality at 30 days or at the longest follow‐up or both. | Study population | RR 0.94 (0.40 to 2.20) | 65 (1 RCT) | ⊕⊝⊝⊝ Very Low 1 2 |
Downgraded two levels due to very serious imprecision (one study, few events), and one level due to indirectness (feasibility study of a cognitive therapy protocol). | |
| 273 per 1000 | 256 per 1000 (109 to 600) | |||||
| Number of delirium‐ and coma‐free days (within the first 30 days) measured by the CAM‐ICU | The mean number of delirium‐ and coma‐free days (30 days) was 23.3 days | 2.8 days lower (10.1 lower to 4.6 higher) | ‐ | 65 (1 RCT) | ⊕⊝⊝⊝ Very low 1 2 3 | Downgraded two levels due to very serious imprecision (one study, few events), and one level due to indirectness (feasibility study of a cognitive therapy protocol).Downgraded one level due to risk of bias (not clearly stated whether assessment of outcome was blinded) |
| Ventilator‐free days (within the first 30 days) | median 27.4 (0.0 to 29.2) | median 25.3 (0 to 28.9) | ‐ | 65 (1 RCT) | ⊕⊝⊝⊝ Very low 1 2 3 | Downgraded two levels due to very serious imprecision (one study, few events), and one level due to indirectness (feasibility study of a cognitive therapy protocol). Downgraded one level due to risk of bias (not clearly stated wether assessment of outcome was blinded) |
| Length of ICU stay (days) | The median length of stay in the ICU was 4.0 days | The median length of stay was 7.9 days | MD 1.23 higher (0.68 lower to 3.14 higher) | 65 (1 RCT) | ⊕⊝⊝⊝ Very low 1 2 3 | Downgraded two levels due to very serious imprecision (one study, few events), and one level due to indirectness (feasibility study of a cognitive therapy protocol). Downgraded one level due to risk of bias (not clearly stated wether assessment of outcome was blinded) |
| Cognitive functioning a): Global functioning (MMSE score 0 ‐ 30, higher score indicating better cognitive function) | The mean cognitive status (MMSE) was 28 points | 0.97 points higher (0.19 lower to 2.13 higher) | ‐ | 30 (1 RCT) | ⊕⊝⊝⊝ Very low 1 2 3 | Downgraded two levels due to very serious imprecision (one study, few events), and one level due to indirectness (feasibility study of a cognitive therapy protocol). Downgraded one level due to risk of bias (not clearly stated whether assessment of outcome was blinded) |
| Cognitive functioning b) Executve functioning (DEX score) (scores range from 0 to 80. Lower scores indicate better functioning) (DEX) | The mean cognitive status (DEX) was 18 points | 8.76 points lower (19.06 lower to 1.54 higher) | ‐ | 30 (1 RCT) | ⊕⊝⊝⊝ Very low 1 2 3 | Downgraded two levels due to very serious imprecision (one study, few events), and one level due to indirectness (feasibility study of a cognitive therapy protocol). Downgraded one level due to risk of bias (not clearly stated wether assessment of outcome was blinded) |
| Adverse events | One patient experienced acute back pain accompanied by hypotensive urgency during physical therapy. | ‐ | 65 (1 RCT) | ⊕⊝⊝⊝ Very low 1 2 3 | Downgraded two levels due to very serious imprecision (one study, few events), and one level due to indirectness (feasibility study of a cognitive therapy protocol).Downgraded one level due to risk of bias (not clearly stated wether assessment of outcome was blinded) | |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CAM‐ICU: confusion assessment method for the ICU; CI: Confidence interval; DEX: Dysexecutive questionnaire; ICU: intensive care unit; OR: MMSE: Mini‐Mental State Examination; RR: Risk ratio | ||||||
| GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect | ||||||
1 Downgraded two levels due to serious impression:single study with few events in a small sample.
2 Downgraded one level due to indirectness: this was primarily a feasibility study of a cognitive therapy protocol
3 Downgraded one level due to risk of bias: not clearly stated wether assessment of outcome was blinded