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Table 11 Razavi et al., 1996

From: Antidepressants in the treatment of depression/depressive symptoms in cancer patients: a systematic review and meta-analysis

Domain

Description

Review author’s judgement

Sequence generation

Randomization method is not described.

“Unclear”

Allocation concealment

The exact method is not described.

“Unclear”

Blinding of participants, personnel, and outcome

Double blind trial. The authors do not address this issue.

“Unclear”

Incomplete outcome data

The main outcome was the number of patients with success criteria (HADS score≤8) and with response criteria (≥50% improvement in HADS score). There were 15 dropouts in the fluoxetine group (FG) and 7 dropouts in the placebo group (PG). The reasons for dropouts in the FG were: 7 due to AEs, 3 decided to interrupt their participation for unknown reasons, 1 due to alcohol abuse, and 4 for other reasons:

“Unclear”

(Non-compliance, investigator’s decision, lost to follow-up). The reasons for dropouts in the PG were: 2 due to concomitant events, 4 for unknown reasons, 1 for psychiatric reasons. The authors used an ITT basis for the success and response rates. The exact missing data imputation method is not being reported.

Selective outcome reporting

No study protocol available. All pre-specified outcomes are reported in the pre-specified way.

“Yes”

Other sources of bias

The study seems to be free of other sources of bias.

“Yes”