Anderson 2005.
Methods |
RCT with a wait‐listed control group Randomisation ratio: 1:1 Superiority design |
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Participants |
Inclusion criteria: not stated; targeted to African Americans in urban area in Detroit Exclusion criteria: not stated Diagnostic criteria: not stated |
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Interventions |
Number of study centres: not stated Treatment before study: 37% overall had previous HE Intervention: 2‐hour weekly group sessions for 6 weeks Control: wait‐listed Provider: certified diabetes educators (nurses) |
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Outcomes |
Outcomes reported in abstract of publication: Primary outcome(s):
Secondary outcome(s): Not specified primary and secondary outcomes |
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Study details |
Run‐in period: 4 years Study terminated before regular end: no |
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Publication details |
Language of publication: English Funding: National Institutes of Health grants and the core of the Michigan Diabetes Research and Training Center Publication status: peer review journal |
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Stated aim of study | Quote from publication: "To evaluate the impact of problem‐based empowerment education program specifically tailored to urban African Americans with type 2 DM" | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: not stated |
Allocation concealment (selection bias) | Unclear risk | Comment: not mentioned |
Blinding of participants and personnel (performance bias) Objective outcomes | High risk | Comment: not stated but from the nature of the intervention unlikely to have been blinded |
Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | Comment: not stated but from the nature of the intervention unlikely to have been blinded |
Blinding of outcome assessment (detection bias) Lab tests: Lipids, HBA1C | Unclear risk | Comment: not mentioned |
Blinding of outcome assessment (detection bias) Subjective outcomes | High risk | Comment: not mentioned but participants completing questionnaires unlikely to have been blinded |
Incomplete outcome data (attrition bias) Objective outcomes | Unclear risk | Comment: roughly equal numbers lost to follow up in control and intervention groups. No mention of ITT analysis |
Incomplete outcome data (attrition bias) Subjective outcomes | Unclear risk | Comment: significant number of control group lost to follow‐up at 6 weeks (33/119) |
Selective reporting (reporting bias) | Unclear risk | Comment: no outcomes appear to have been missed but no protocol available |
Other bias | Unclear risk | Comment: none |