Schatz 2015.
Methods | RCT. 2 arms. Assessed at pretreatment and post‐treatment | |
Participants | End of treatment: N = 46 Start of treatment: N = 48 Sex: 27 F, 19 M Mean age: 13.04 (SD 2.5) Source: clinic Diagnosis: sickle cell disease Mean years of pain: lifelong | |
Interventions | "CBT coping skills training" "Waitlist standard care" |
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Outcomes |
Primary pain outcome: pain intensity
Primary disability outcome: activity score from daily diary Primary depression outcome: none Primary anxiety outcome: none Primary satisfaction outcome: none Measures reported: daily pain diary and activity log Coping Strategies Questionnaire |
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Notes |
Funding statement: this work was supported by the National Institutes of Health, National Heart, Lung, and Blood Institute (R21HL0923365 to J.S. and C.B.M. and T32 GM081740 and F31HL108582 to A.M.S.) Declaration of interest: the authors declare no conflicts of interest |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Randomization was achieved by drawing colored marbles out of an opaque bag (wave 1) or by computer software using blocks of 10 (wave 2)." |
Allocation concealment (selection bias) | Low risk | "A researcher not involved in study data collection prepared sequentially numbered, opaque, sealed envelopes that assigned each participant and were opened by the youth." |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No description found in text Comment: probably not done |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Participants completed questionnaires electronically |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Attrition completely reported; significant differences between completers and non‐completers were not reported |
Selective reporting (reporting bias) | High risk | Data incompletely reported |