Middelkoop 2001.
Methods |
Parallel randomised controlled clinical trial (RCT) (for first 6 months) Randomisation ratio: 53 intervention:60 control Superiority design |
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Participants |
Inclusion criteria:
Exclusion criteria: not stated Diagnostic criteria: not stated |
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Interventions |
Number of study centres: 3 general practices and 1 outpatient clinic Treatment before study: not stated Intervention: attending to intensive guidance clinics (approximately 4‐7 visits for the first 3 months, with less frequent subsequent visits) provided by trained nurse and dietician Control: wait‐listed group that joined the intervention group after 6 months Provider: specialist nurse and dietician trained in South Asian culture |
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Outcomes |
Outcomes reported in abstract of publication: Primary outcome(s): HbA1c Secondary outcome(s): not assessed for RCT component of the intervention |
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Study details |
Run‐in period: not stated Study terminated before regular end: no |
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Publication details |
Language of publication: English Funding: not stated Publication status: peer‐reviewed journal |
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Stated aim of study | Quote from publication: "To assess if culturally‐specific diabetes intervention led to a decrease HbA1c level, improvement in lipid profile, or a decrease in BMI" | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Quote from publication: "Patients were randomised based on their date of birth: odd numbers (intervention patients)" |
Allocation concealment (selection bias) | Unclear risk | Comment: not mentioned |
Blinding of participants and personnel (performance bias) Objective outcomes | Unclear risk | Comment: not clear whether participants would have been aware of whether they were in the control group |
Blinding of participants and personnel (performance bias) Subjective outcomes | Unclear risk | Comment: no subjective outcomes |
Blinding of outcome assessment (detection bias) Lab tests: Lipids, HBA1C | Low risk | Comment: does not mention whether laboratory technicians blinded but unlikely to have affected HbA1c |
Blinding of outcome assessment (detection bias) Subjective outcomes | Unclear risk | Comment: no subjective outcomes |
Incomplete outcome data (attrition bias) Objective outcomes | Unclear risk | Comment: 28/60 of control group lost to follow‐up as changed GP, does not provide further details of other participants lost to follow‐up |
Incomplete outcome data (attrition bias) Subjective outcomes | Unclear risk | Comment: no subjective outcomes |
Selective reporting (reporting bias) | Unclear risk | Comment: HbA1c was only outcome in RCT reported on but protocol not seen (e.g. may have specified that investigators would look at BMI at 6 months) |
Other bias | Unclear risk | Comment: none |