Tepel 2008.
Study characteristics | ||
Methods |
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Participants |
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Interventions | Treatment group (dihydropyridine CCB)
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) | Low risk | QUOTE: "A computer‐generated randomisation list was prepared centrally" |
Allocation concealment (selection bias) | Low risk | QUOTE: "A computer‐generated randomisation list was prepared centrally guaranteeing that in study centres patients were assigned to one of both treatment groups" QUOTE: "To ensure allocation concealment, sequentially numbered containers were used" No indication whether the containers were identical. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | QUOTE: "Double blind" Review of the protocol on clinicaltrials.gov (NCT00124969) revealed that participants and personnel were blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | QUOTE: "Deaths were classified by the treating physician independently of the endpoint analysis" Review of the protocol on clinicaltrials.gov (NCT00124969) revealed that the outcome assessors were blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | QUOTE: "No patient was lost to the follow‐up" (analysis was by intention‐to‐treat population) |
Selective reporting (reporting bias) | Low risk | All outcomes prespecified were reported |
Other | Low risk | QUOTE: "The study sponsor did not take part in collection, analysis or interpretation of data, or in the writing of the report." The study seemed to be free from other source of bias |