Tiller 1981.
Study characteristics | ||
Methods |
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Participants |
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Interventions | Treatment group
Control group
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Outcomes |
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Notes |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information about the sequence generation process to permit judgement |
Allocation concealment (selection bias) | Unclear risk | No sufficient detail about concealment of the random allocation sequence before or during enrolment of participants |
Blinding of participants and personnel (performance bias) All outcomes | High risk | open‐label study |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information to permit judgement |
Incomplete outcome data (attrition bias) All outcomes | High risk | 29/54 patients (54%) completed the 36‐month follow‐up: 14/27 (52%) in the treatment group and 15/27 (56%) in the control group. The missing numbers of patients were balanced and the missing reason was specified in each patient. The rate of loss to follow‐up was high (54%), intention‐to‐treat principle was used to deal with these data to avoid potential bias |
Selective reporting (reporting bias) | Low risk | The primary outcomes and key adverse effects were detailed in the publication, although other outcomes were not available to be included in this meta‐analysis |
Other bias | Unclear risk | Insufficient information to permit judgement |