Summary of findings 3. CBT with therapist support compared to fatigue information leaflet only for participants with IBD.
| CBT with therapist support compared to fatigue information leaflet only for participants with IBD | ||||||
| Patient or population: participants with IBD Setting: outpatients from a single centre in the United Kingdom Intervention: CBT with therapist support Comparison: fatigue information leaflet only | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with fatigue information leaflet only | Risk with CBT with therapist support | |||||
| Fatigue assessed with: IBD‐F Section I follow‐up: 3 months | The mean fatigue score was 9.45 | MD 2.16 lower (6.13 lower to 1.81 higher) | ‐ | 18 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 1 2 | IBD‐F Section I scores ranged from 0 to 20, with higher scores indicating greater levels of fatigue. |
| Fatigue assessed with: IBD‐F Section II Scale from: 0 to 120 follow‐up: 3 months | The mean fatigue score was 47.33 | MD 21.62 lower (45.02 lower to 1.78 higher) | ‐ | 16 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 1 2 | IBD‐F Section II scores ranged from 0 to 120, with higher scores indicating greater impact of fatigue. |
| Quality of life assessed with: UK‐IBDQ follow‐up: 3 months | The mean quality of life score was 95.7 | MD 0.19 higher (9.32 lower to 9.7 higher) | ‐ | 19 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 1 2 | UK‐IBDQ scores ranged from 32 to 224, with higher scores indicating better quality of life. |
| Adverse events | ‐ | ‐ | ‐ | ‐ | This outcome was not measured. | |
| Serious adverse events | ‐ | ‐ | ‐ | ‐ | This outcome was not measured. | |
| Withdrawal due to adverse events | ‐ | ‐ | ‐ | ‐ | This outcome was not measured. | |
| *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). CI: Confidence interval; RR: Risk ratio; OR: Odds 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 for very serious imprecision; small number of participants from a single study and the confidence interval was wide.
2 Downgraded one level due to risk of bias in blinding of participants and personnel and blinding in outcome assessment.