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. 2020 Mar 3;2020(3):CD012681. doi: 10.1002/14651858.CD012681.pub2

Verberne 2012.

Methods Study design: cross‐sectional study
Instrument used to assess fatigue: PedsQL Multidimensional Fatigue Scale
Validated questionnaire: yes
Cut‐off score or criterion for severe fatigue: normative mean total score for Dutch population of the PedsQL child form: 76.84 (SD 12.67); cut‐off score for severe fatigue: total fatigue score < 51.50
Time points at which outcome data were collected: NA, cross‐sectional study
Inclusion criteria: between 4 and 18 years old, > 6 months after end of treatment, diagnosed after 2003
Exclusion criteria: Down syndrome
Participants Sample characteristics:
N of participants original cohort: unknown; N of participants described study group: 109; N of participants study group of interest: 109; N of participants fatigue assessed: 109, 71 with child forma
Participant characteristics:
Tumour type: CNS tumour n = 31, HL n = 4, NHL n = 11, ALL n = 12, WT n = 13, neuroblastoma n = 7, bone tumour n = 7, non‐CNS germ cell tumour n = 4, liver tumour n = 3, soft tissue or other tumour n = 17
Tumour stage: nm
Age at diagnosis: mean 7.1 years (range 0.0 ‐ 16.9)
Time since end of therapy: mean 2.4 years (range 0.5 ‐ 6.0)
Age at assessment: mean 10.3 years (range 4.0 ‐ 17.9)
F/M: 48/61
BMI: < 25 n = 60, ≥ 25 ‐ ≤ 30 n = 5, > 30 n = 3, unknown n = 3
Race/ethnicity: White n = 47, Hispanic n = 0, other n = 14, unknown n=10
Marital status: NA
Highest completed education level: nm
Employment: NA
Physical activity level: nm
Sleeping problems: sleep duration: 9 ‐ 11 hrs n = 62, 8 ‐ 9 hrs n = 26, 7 ‐ 8 hrs n = 13, 5 ‐ 7 hr n = 3, < 5 hr n = 1b
DIMS: mean 11.7 (SD 3.8)c
 SWTD: mean 7.8 (SD 2.6)c
 DOES: mean 8.8 (SD 2.8)c
 SHY: mean 2.6 (SD 1.6)c
Daytime sleepiness (ESS): mean 4.5 (SD 4.0)c
Psychosocial problems: nm
 Comorbidities/late effects: nm
Genetic factors/mutations: nm
Interventions N of participants surgery: 20
N of participants surgery + chemotherapy: 34
 N of participants surgery + chemotherapy + cranial irradiation: 11
N of participants surgery + chemotherapy + radiotherapy: 12
N of participants surgery + radiotherapy: 2
N of participants chemotherapy: 20
N of participants chemotherapy + radiotherapy: 7
N of participants no treatment: 3
Outcomes Severe fatigue:
N of participants with severe fatigue: 8/71 (11.3%)
Risk and associated factors:
Dependent factor: fatigue (continuous)d
Univariable:
Significant: DOES ( r = −0.78, P < 0.001), SWTD (r = −0.37, P < 0.05)
Non‐significant: DIMS (r = −0.15), SHY (r = −0.08), daytime sleepiness (r = −0.30)
Notes Funding sources: This study was not funded
Declaration of interest: The authors declare that there is no conflict of interest
The following data were obtained from the study author: N of participants with severe fatigue, BMI and race/ethnicity
aonly for the participants that filled in the child form of the PedsQL questionnaire (8 ‐ 18 years at assessment), fatigue was assessed based on the presented criterion for severe fatigue.
bNumbers do not add up to total N of described study group. Unclear what correct numbers were.
cPresented means are from CNS tumour survivors only
dAnalyses were performed with fatigue score on a continuous scale as outcome (Pearson correlation). P values were not reported for non‐significant risk and associated factors in the article. Analyses included only CNS tumour survivors
Risk of bias
Bias Authors' judgement Support for judgement
Representative study group (selection bias) High risk Size of original cohort is unclear, 129 eligible participants, 109 described study group, < 90%
Adequate follow‐up assessment (attrition bias) Low risk Outcome was assessed for 65% ‐ 95% of the study group of interest
Blinded outcome assessor (detection bias) 
 All outcomes High risk The outcome assessors were not blinded to the investigated determinant
Adjustment important confounders High risk No multivariable analyses
Well‐defined study group (reporting bias) Unclear risk Type of cancer and cancer treatment are mentioned but information about specific chemotherapeutic agents and doses are not reported. Inclusion and exclusion criteria are described
Well‐defined follow‐up (reporting bias) Low risk Length of follow‐up is mentioned
Well‐defined outcome severe fatigue (reporting bias) 
 All outcomes Low risk The authors reported which instrument they used to assess fatigue; definition of severe fatigue is based on data query
Well‐defined outcome fatigue (reporting bias) Low risk Authors reported which instrument they used to assess fatigue, and how they described fatigue (continuous scale)
Well‐defined risk estimation Low risk Correlation coefficients are calculated