Hawthorne 1997.
Methods |
Parallel randomised controlled clinical trial (RCT) Randomisation ratio: 113 intervention:89 control Superiority design |
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Participants | Pakistani Moslems with type 2 DM Inclusion criteria::
Exclusion criteria:
Diagnostic criteria: not stated—from medical history |
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Interventions |
Number of study centres: 10 general practices and 1 hospital diabetes clinic Treatment before study: none had previous diabetes HE Intervention: 1 session of 1‐to‐1 pictorial flash cards HE (purpose of glucose monitoring, how to control blood sugar, diabetic complications and purpose of regular screening) with a trained link worker Control: not stated Provider: trained link worker |
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Outcomes |
Outcomes reported in abstract of publication: Primary outcome(s):
Secondary outcome(s):
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Study details |
Run‐in period: 6 months Study terminated before regular end (for benefit/because of adverse events): no |
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Publication details |
Language of publication: English Funding: Central Manchester Hospitals Trust Research Grant Publication status: peer‐reviewed journal |
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Stated aim of study | Quote from publication: "To develop and evaluate a set of culturally appropriate flashcards one to one diabetes education intervention" | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote from publication: "patient[s] were allocated to control or intervention groups as they presented at clinics, using pre‐sealed envelopes and random number tables" |
Allocation concealment (selection bias) | Low risk | Comment: sealed envelopes opened by researcher on allocation to intervention/control |
Blinding of participants and personnel (performance bias) Objective outcomes | High risk | Comment: does not mention whether participants/personnel were blinded, although unlikely to have been due to the nature of the intervention |
Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | Comment: does not mention whether participants/personnel were blinded, although unlikely to have been due to the nature of the intervention |
Blinding of outcome assessment (detection bias) Lab tests: Lipids, HBA1C | Low risk | Comment: lack of blinding unlikely to affect outcome |
Blinding of outcome assessment (detection bias) Subjective outcomes | High risk | Comment: participants completing questionnaires unlikely to have been blinded |
Incomplete outcome data (attrition bias) Objective outcomes | Low risk | Comment: under 5% attrition rate, roughly balanced, gives reasons overall but not for each group. ITT analysis not used? |
Incomplete outcome data (attrition bias) Subjective outcomes | Low risk | Comment: under 5% attrition rate, roughly balanced, gives reasons overall but not for each group. ITT analysis not used? |
Selective reporting (reporting bias) | Unclear risk | Comment: protocol not seen |
Other bias | Unclear risk | Comment: none |