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Interventions for the management of fatigue in adults with a primary brain tumour

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Appendices

Appendix 1. MEDLINE search strategy

1 exp Fatigue/
2 Lethargy/
3 Asthenia/
4 (fatigue* or lassitude or weary or weariness or tired or exhausted or exhaustion or lethargy or asthenia or ((lack* or loss*) adj5 energy)).mp.
5 1 or 2 or 3 or 4
6 exp Brain Neoplasms/
7 exp Glioma/
8 Meningioma/
9 (brain adj5 (tumor* or tumour* or carcinoma* or malignan* or neoplas* or cancer*)).mp.
10 (glioma* or astrocytoma* or oligodendroglioma or ependymoma* or medulloblastoma* or meningioma*).mp.
11 6 or 7 or 8 or 9 or 10
12 5 and 11

Key:

mp = title, abstract, original title, name of substance word, subject heading word, keyword heading word, protocol supplementary concept word, rare disease supplementary concept word, unique identifier
pt = publication type
ab = abstract
fs = floating subheading

Appendix 2. 'Risk of bias' assessment tool

1. Random sequence generation

  • Low risk of bias, e.g. participants assigned to treatments on basis of a computer‐generated random sequence or a table of random numbers

  • High risk of bias, e.g. participants assigned to treatments on basis of date of birth, clinic id‐number or surname, or no attempt to randomise participants

  • Unclear risk of bias, e.g. not reported, information not available

2. Allocation concealment

  • Low risk of bias, e.g. where the allocation sequence could not be foretold

  • High risk of bias, e.g. allocation sequence could be foretold by patients, investigators or treatment providers

  • Unclear risk of bias, e.g. not reported

3.1. Blinding of participants and personnel

Assessment of blinding will be restricted to pharmacological interventions, since it would not be possible to blind participants and treatment providers to the non‐pharmacological interventions.

  • Low risk of bias, if participants and personnel were adequately blinded

  • High risk of bias, if participants were not blinded to the intervention that the participant received

  • Unclear risk of bias, if this was not reported or unclear.

3.2. Blinding of outcomes assessors

  • Low risk of bias, if outcome assessors were adequately blinded

  • High risk of bias, if outcome assessors were not blinded to the intervention that the participant received

  • Unclear risk of bias, if this was not reported or unclear

4. Performance Bias

  • Low risk of bias, e.g. both groups were followed on similar schedules of neurologic exam and brain imaging

  • High risk of bias, e.g. each group was followed according to different schedules

  • Unclear risk of bias, e.g. not reported or incomplete reporting of outcome data

We will record the proportion of participants whose outcomes were not reported at the end of the study.

5. Incomplete outcome data

We will record the proportion of participants whose outcomes were not reported at the end of the study. We will code a satisfactory level of loss to follow‐up for each outcome according to the following.

  • Low risk of bias, if fewer than 20% of patients were lost to follow‐up, and reasons for loss to follow‐up were similar in both treatment arms

  • High risk of bias, if more than 20% of patients were lost to follow‐up, or reasons for loss to follow‐up differed between treatment arms

  • Unclear risk of bias, if loss to follow‐up was not reported

6. Selective reporting of outcomes

  • Low risk of bias e.g. review reports all outcomes specified in the protocol

  • High risk of bias e.g. it is suspected that outcomes had been selectively reported

  • Unclear risk of bias e.g. it is unclear whether outcomes had been selectively reported

7. Other bias

  • Low risk of bias ‐ if we do not suspect any other source of bias and the trial appears to be methodologically sound

  • High risk of bias ‐ if we suspect that the trial was prone to an additional bias

  • Unclear risk of bias ‐ if we are uncertain whether an additional bias may have been present