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Table 4 Grade evidence summary

From: The effectiveness of psychological interventions for fatigue in cancer survivors: systematic review of randomised controlled trials

Outcomes

№ of participants (studies)

Certainty of the evidence

Explanations

Psychological Interventions compared to usual care for Fatigue in cancer survivors

Follow up: range 2 weeks to 1 years

Intervention: Psychological Interventions

Comparison: usual care

2918

(22 RCTs)

LOW a, b

a. Downgraded x 1 level for risk of bias due to all studies having high or unclear risk of performance bias. Many aspects of trial procedures were not reported in sufficient detail to adequately assess risk of bias in all domains of all included trials (e.g. unclear risk of selection bias in 18/22 studies, unclear risk of detection bias in16/22).

b. Downgraded x1 level for indirectness of evidence as many studies were combined interventions, which limit our ability to draw conclusions in relation to our research question relating solely to the effectiveness of psychological interventions. Generalizability of the findings are limited due to the high proportion of studies that recruited only/mostly breast cancer survivors. The majority of studies did not specifically target fatigue or screen for fatigue as part of inclusion criteria as recommended in existing guidelines. In some studies, it was difficult to assess when exactly participants completed cancer treatment prior to participating in the study. High levels of heterogeneity in sample and methods.

Subgroups of specific psychological intervention type (e.g. cognitive behavioural therapy) vs usual care

CBT interventions compared to usual care for Fatigue in cancer survivors

Follow up: range 1 months to 1 years

648(8 RCTs)

LOWa, b

a. Downgraded x 1 level for risk of bias due to high/ unclear risk due to incomplete outcome data (attrition bias) in 5 of 8 studies Many aspects of trial procedures were not reported in sufficient detail to adequately assess risk of bias.

b. Downgraded x1 level for indirectness of evidence as high levels of heterogeneity in sample and methods that limit the generalizability of the findings- While CBT was incorporated in all interventions to some degree, it was delivered in a variety of settings, modes and assessed in different ways. For example, 3 x studies were not CBT interventions but were based on CBT strategies and 3x studies were focused specifically on CBT for insomnia.

Mindfulness-based interventions compared to usual care for Fatigue in cancer survivors

Follow up: range 1 months to 4 months

749(6 RCTs)

LOW a, b

a. Downgraded x 1 level for risk of bias due to high or unclear risk of performance bias in all studies. Many aspects of trial procedures were not reported in sufficient detail to adequately assess risk of bias.

b. Downgraded x1 level for indirectness of evidence as high levels of heterogeneity in sample and methods that limit the generalizability of the findings- While mindfulness was incorporated in all interventions to some degree, it was delivered in a variety of settings, modes and assessed in different ways.

Other psycho-social interventions compared to usual care for Fatigue in cancer survivors

Follow up: range 3 months to 12 months

1521(8 RCTs)

LOW a, b

a. Downgraded x 1 level for risk of bias due to high or unclear risk of performance bias in all studies Some aspects of trial procedures were not reported in sufficient detail to adequately assess risk of bias

b. Downgraded x1 level for indirectness of evidence as high levels of heterogeneity - While all were psychological interventions, they were vastly different in sample and methods. Further, 4 x studies were lifestyle interventions that incorporated other interventions such as physical activity and dietary changes.

  1. GRADE Working Group grades of evidence
  2. High certainty: We are very confident that the true effect lies close to that of the estimate of the effect
  3. 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
  4. Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
  5. 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