Berbis 2013.
| Methods | Study design: cross‐sectional study (questionnaire survey) Instrument used to assess fatigue: SF‐36 Vitality subscale Validated questionnaire: yes Cut‐off score or criterion for severe fatigue: score ≤ 50 Time points at which outcome data were collected: NA, cross‐sectional study Inclusion criteria: diagnosis of de novo AML or de novo ALL since January 1980 (not excluding secondary leukaemias), < age 18 years at the time of diagnosis, complete remission 24 months after the diagnosis for AML participants and ALL participants grafted in first complete remission or complete remission at 48 months after the diagnosis for ALL participants not grafted in first complete remission; agreement to participate in the study with parents or legal guardians authorising participation for any child < age 18 years Exclusion criteria: nm |
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| Participants | Sample characteristics: N of participants original cohort: 1115; N of participants described study group: 943; N of participants study group of interest: 943; N of participants fatigue assessed: 431a Participant characteristics: Tumour type: ALL n = 807, AML n = 136 Tumour stage: nm Age at diagnosis: mean 6.4 years (SD 4.2) Time since diagnosis: mean 11.9 years (SD 6.4) Age at assessment: mean 18.3 years (SD 7.1); < 8 years n = 55, 8 ‐ 10 years n = 102, 11 ‐ 17 years n = 294, > 18 years n = 492 F/M: 423/520 BMI: overweight (BMI ≥ 25) n = 346 Race/ethnicity: nm Marital status: nm Highest completed education level: nm Employment: nm Physical activity level: nm Sleeping problems: nm Psychosocial problems: nm Comorbidities: at least 1 late event n = 674, height growth failure n = 375, gonadal dysfunction n = 129/706, hypothyroidism n = 75, second tumour n = 46, bone mineral deficiency n = 11/163, alopecia n = 32, cardiac side effect n = 24, cataract n = 115, severe neurological dysfunctions n = 22, diabetes n = 6, iron overload n = 91, osteonecrosis n = 24, viral transmission n = 18, metabolic syndrome n = 26/298 Genetic factors/mutations: nm |
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| Interventions | N of participants surgeryb: 0 N of participants only chemotherapyb: 203 N of participants radiotherapy and chemotherapyb: 93 N of participants chemotherapy and SCT with or without radiotherapyb: 135 N of participants cranial irradiation: 148 N of participants testicular irradiation: 21 N of participants testicular irradiation boost: 24 N of participants total body irradiation: 186 N of participants SCT: 256 |
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| Outcomes | Severe fatigue: N of participants with severe fatigue: 128/431 (29.70%) Risk and associated factors: Dependent factor: no analysis performed with fatigue as outcome |
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| Notes | Funding sources: Supported by the French national cancer institute (InCa) and the regional council PACA Declaration of interest: Nothing to declare The following data were obtained from the study author: N of participants with severe fatigue a the SF‐36 questionnaire was only administered to the adult survivors (age at assessment > 18 years) b numbers are based on the survivors for whom fatigue could be assessed (n = 431) |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Representative study group (selection bias) | High risk | The described study group consisted of < 90% of the original cohort |
| Adequate follow‐up assessment (attrition bias) | High risk | Outcome was assessed for < 65% of the study group of interest |
| Blinded outcome assessor (detection bias) All outcomes | High risk | Outcome assessors were not blinded to the investigated determinant |
| Well‐defined study group (reporting bias) | Unclear risk | Type of cancer and cancer treatment are mentioned but information about specific 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 |