Khan 2014.
Methods | Study design: cross‐sectional study Instrument used to assess fatigue: Brief Fatigue Inventory Validated questionnaire: yes Cut‐off score or criterion for severe fatigue: mean score > 7a Time points at which outcome data were collected: NA, cross‐sectional study Inclusion criteria: treatment on institutional protocol, at least 5 years from the time of ALL diagnosis, at least 1 year from completion of all cancer therapy, English as a primary language, absence of a pre‐existing cognitive disorder preventing study evaluation Exclusion criteria: nm |
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Participants | Sample characteristics: N of participants original cohort: unknown; N of participants described study group: 162; N of participants study group of interest: 162; N of participants fatigue assessed: 162 Participant characteristics: Tumour type: ALL n = 162 Tumour stage: nm Age at diagnosis: median 3.9 years (range 0.4 ‐ 18.6) Time since diagnosis and/or end of therapy: median 10.2 years (range 5 ‐ 22.7) and median 7.4 years (range 1.9 ‐ 20.3) Age at assessment: median 15.7 years (range 6.9 ‐ 29.0) F/M: 72/90 BMI: nm Race/ethnicity: White n = 146 Marital status: nm Highest completed education level: nm Employment: nm Physical activity level: nm Sleeping problems: nm Psychosocial problems: nm Comorbidities: pre‐hypertension n = 15, definite hypertension n = 6, seizures n = 17, back pain n = 37 Genetic factors/mutations: nm |
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Interventions | N of participants chemotherapy: 162 N of participants cranial irradiation: 23 N of participants surgery: 0 N of participants SCT: 0 Received chemotherapeutic agents: triple intrathecal therapy with cytarabine, methotrexate and hydrocortisone: n = 162 |
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Outcomes | Severe fatigue: N of participants with severe fatigue: 3/162 (1.9%) Risk and associated factors: Dependent factor: mild to severe fatigue (yes/no)b Multivariable: Significant: relapse (OR 8.35 (95% CI 1.16 to 59.93), P = 0.03) |
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Notes | Funding sources: Grant CA21765 from the National cancer institute and by the Lebanese Syrian associated charities Declaration of interest: nothing to declare aNot every survivor completed the BFI, only if the screening question was positive for fatigue/energy loss bAnalysis was performed with mild to severe fatigue as outcome (mean score ≥ 1). It is unclear which other variables were included in the multivariable model |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Representative study group (selection bias) | High risk | Size of original cohort is unclear, 432 eligible participants, 162 described study group, < 90% |
Adequate follow‐up assessment (attrition bias) | Low risk | Outcome was assessed for > 95% of the study group of interest |
Blinded outcome assessor (detection bias) All outcomes | High risk | Outcome assessors were not blinded to the investigated determinant |
Adjustment important confounders | Unclear risk | Unclear which other variables were included in multivariable model |
Well‐defined study group (reporting bias) | Unclear risk | Type of cancer and cancer treatment are mentioned but information about doses is 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 and what they considered to be severe fatigue |
Well‐defined outcome fatigue (reporting bias) | Low risk | Authors reported which instrument they used to assess fatigue, and how they described fatigue (mild to severe fatigue) |
Well‐defined risk estimation | Unclear risk | Odds ratio is provided for significant factor. Unclear which other variables were included in multivariable model. |